Links to 1317 Entry-Level Biotechnology & Life Science Jobs

The Field Service Technician (FST) performs planned maintenance, repairs and other verification/qualification services on a variety of laboratory instruments in assigned territory. The FST engages with customers and provides basic instrument services in a professional and timely manner. What will you do? Provides planned maintenance (PM), basic repair services and temperature verifications. Displays professionalism, understanding, tact, fairness and technical knowledge in all customer interactions. Follows all reporting responsibilities of Remote Service Dispatch (RSD), Escalation, Field Problem Report (FPR) and Field Service Report (FSR) submissions. etc.

You will join a team of bioinformatics scientists developing and supporting genotyping microarrays for human and animal research. Your work will help determine the success of both internal and customer projects. What will you do? Develop and implement software tools and pipelines for analysis and troubleshooting. Analyze genotyping data for customers and internal projects. Participate in multifunctional teams to develop new methods and launch new products.

The Resin Manufacturing Team in Sunnyvale, CA is responsible for producing many of functionalized resins that are the key to the success of Thermo Fisher’s Ion Chromatography portfolio. We are seeking an energetic individual with strong communication, technical and operational skills to join our dynamic and fast paced team. This position will provide direct labor to the Ion Chromatography and Sample Preparation business unit. The candidate will follow SOPs and work in compliance with safety, regulatory and quality guidelines. etc.

TriLink Biotechnologies is seeking a Material Handler I. This position will help maintain warehouse stock and assist in fulfilling orders in order to meet long-term growth and profitability targets. Preference will be given to candidates available to work overtime and/or weekend hours during the busier times of the year and able to lift up to 50-60 pounds at a time. This role will serve as a point of contact for daily execution within the organization and work closely with Manufacturing, Operations, Quality, R&D, and Commercial to sustain production and help us take the next steps forward in our high-growth cycle. etc.

We are looking for an outstanding Research Associate (RA) or Sr. RA to join our R&D team. The Research Associate will support R&D efforts in developing custom DNA-based applications and assays for synthetic biology and Next Generation Sequencing Target Enrichment products. The ideal candidate will be driven and willing to learn new techniques. This position will support projects including high-throughput gene synthesis, high-throughput cloning processes, NGS target enrichment workflows, NGS-based QC, etc.

The Network Systems Analyst will be primarily responsible for managing and configuring security information and event monitoring (SIEM) tool. Research security enhancements and identifies solutions to enhance IT security. Evaluates and recommends security products, services, and/or procedures to enhance productivity and effectiveness. Provides technical support of IT infrastructure at all Upsher-Smith locations. Support will include assisting with installation, configuration, recovery, administration and security of infrastructure components. Incumbent will work on implementation projects as well as have responsibility for daily monitoring and support activities. etc.

United States Biological is a local, growing manufacturing company seeking enthusiastic individuals to be part of our team. We specialize in thousands of antibodies, ultra pure molecular biology reagents, cell culture media and enzymes. Troubleshoot and provide hands-on support to all personnel. Work with company president on all areas of website, graphics and IT. Set up and format new workstations as needed. Design and create newsletters. Maintain systems, databases and website, as needed.

The Vault Performance Engineering Team works within the Vault Development Team and participates in all phases of the software development life cycle. What You'll Do: Test new features pre-production to make sure they will scale and perform. Collaborate with Vault team members in Product Management, Engineering Management and Quality Assurance to help design and develop performance tests. Implement and execute load tests in JMeter. Use and update Python scripts for managing test systems. Work with Senior Performance Engineers to profile code and identify bottlenecks.

Veeva Systems is looking for an energetic and enthusiastic Engineer to join our rapidly growing team. This is a hands-on position for delivering a quality SaaS product. As part of Veeva CRM Multi Channel software QA team, you will be given an opportunity to test a high quality product that was built from scratch. We are a fast-paced team who takes pride in building great software and making customers happy. What You'll Do: Design and implement test strategies. Develop deep expertise in the product. Build effective test cases that are used for manual and automation testing. etc.

Responsible for performing validation in a GMP biotech manufacturing facility. Core Responsibilities: Perform validation activities in the media preparation, cell culture, utilities and QC areas of a cGMP biotech manufacturing facility. Perform hands on execution of Installation, Operational and Performance Qualifications for equipment, facilities, utilities, as well as cleaning, sterilization, and manufacturing processes in accordance with predefined test protocols. Analyze validation results and compile data into reports for initial qualifications and re-qualifications. Coordinate testing schedule with impacted area managers and quality control based on project needs. Provide input to technical composition of standard operating procedures. etc.

What you'll do: Perform and enable high-throughput sample processing and RNA extraction for transcriptomic analysis, which impacts all drug discovery and development efforts. Successfully conduct library prep of samples for RNAseq. Have the opportunity to learn across function and discipline, by contributing to ongoing studies and by utilizing techniques such as cell culture, high-throughput screening, plasmid preparation, virus preparation, IF, qPCR, or WB. Be responsible for evaluating and presenting your work at team and company level meetings.

Verve is seeking an Associate Scientist with experience in in vivo pharmacology to execute pivotal studies in rodents. You will be responsible for planning gene editing studies in mice and rats, dosing of animals (IV or IP), collecting blood samples (serial and terminal bleeds), necropsy and tissue harvesting. In addition, you will be analyzing the collected samples using a series of ex vivo and in vitro assays. The role requires hands-on experience in rodent handling, dosing and sampling as well as the ability to develop and run assays such as ELISA, qPCR or FACS. The scientist in this position will be part of an integrated R&D project team.

Prepare laboratory specimens for analysis and testing, Spin samples, pour urine tubes, and create frozen samples, Pick up and deliver samples to, clients/hospitals, Unpack and route specimen to their respective staging areas, Accurately identify and label specimens, Pack and ship specimen to proper testing facilities, Properly prepare and store excess specimen samples

Prepare laboratory specimens for analysis and testing, Spin samples, pour urine tubes, and create frozen samples, Pick up and deliver samples to, clients/hospitals, Unpack and route specimen to their respective staging areas, Accurately identify and label specimens, Pack and ship specimen to proper testing facilities, Properly prepare and store excess specimen samples

Our LabCorp office in Oklahoma is expanding its team and looking for dynamic individuals to be Specimen Accessioner (s) who will perform specimen preparation duties. Their work involves receiving and unpacking specimens, preparing them for lab tests and ensuring that they are correctly preserved before they are sent off.

The Associate Regulatory Affairs Specialist (ARAS) is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the US and International Regions. The Regulatory Affairs Specialist will provide support for regulatory activities including: technical writing to support regulatory submissions, product labeling and instructions for use creation.

This position has the responsibility and authority to apply education and learned knowledge toward developing world class medical products for Spinal surgery. Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development. Uses multidisciplinary engineering knowledge to design and develop medical devices or components / subsystems in support of strategic plans.

Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.

The Restorative Therapies Group (RTG) develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes. Within RTG the Supplier Quality department focuses on developing Supplier Owned Quality (SOQ). This is a process allowing suppliers to use portal system in which supplier data is electronically transmitted to Medtronic via an Internet or secure FTP port. The portal system provides real-time material acceptance confirmation, shipment authorization and feedback to supplier prior to release of the product and identifies opportunities to reduce variation in the process. It also reduces the burden on Incoming Quality Assurance.

The function of this position is to provide technical support for ourfacility while actively supporting, participating in, and embracing an empowered culture. This role is for Off-Shift Engineering Support (3rd shift Monday through Friday). Specifically, the position will be required to: Provide on-the-floor support of operational and technical issues; collaborating with the shop floor to provide immediate responses to deviations and potential deviations. Performing deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc

The function of this position is to provide technical support for our facility while actively supporting, participating in, and embracing an empowered culture. This role is for Off-Shift Engineering Support (2nd Shift Monday through Friday). Specifically, the position will be required to: Provide on-the-floor support of operational and technical issues; collaborating with the shop floor to provide immediate responses to deviations and potential deviations.Performing deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc

The entry level Chronic Care Representative (CCR) is the primary point of contact for a variety of customers within their assigned geography. The Chronic Care Representative is a key member of the local Customer Team that works collaboratively with other Company field-based employees such as the Account Executives, Integration Delivery Systems leaders as well as other members of the extended team. Professionals to align customer needs and Company products in accordance with product labeling.

The Clinical Research Associate assists in the administrative of clinical research projects including development of key study documents, over-site of the clinical trial, and ensuring the quality and integrity of the data according to GCP, ICH and SOPs. Interact with data management and study sites with generation and reconciliation of queries in order to meet business timelines. Provide answers to common protocol study related questions under the supervision of the Clinical Director or Associate Trial Manager

We are looking for an Entry-Level Laboratory Sample Receiving Technician to sit in our Madison, WI location. Receive and log in sample in preparation for analysis. Review sample and any attached documentation to assign an identification number and enter information into Laboratory Information Management System (LIMS). Prepare documentation as necessary. Contact client, when necessary, to obtain and clarify missing or unclear information to ensure that identification of client code, test code, and sample contents are accurate. Store sample in appropriate manner until analysis is completed and appropriately dispose of extra sample. Ensure sample integrity is maintained.

The incumbent is responsible for performing chemical analysis on food/pharmaceutical samples. The incumbent analyzes the concentration of certain components in food samples. The incumbent must accurately prepare and process the samples to obtain the needed results. This position reports to the Supervisor of Chemistry. Ensure that proper analysis methods are conducted on the appropriate samples. Maintain chemistry quality control records and procedures for each test. Extract desired components from samples with appropriate processes such as distillation, solvent extraction and acid digestion, so that concentrations can be determined.

Work as a member of a team to prepare food samples for testing. Carry out a number of procedures including reading test labels and preparing samples for analysis by recording, weighing and blending. Pipette sample solution into tubes or plates according to the analysis process being performed. Set up and sterilizing equipment needed for analysis of food samples.

Work as a member of a team to prepare food samples for testing. Carry out a number of procedures including reading test labels and preparing samples for analysis by recording, weighing and blending. Pipette sample solution into tubes or plates according to the analysis process being performed. Set up and sterilizing equipment needed for analysis of food samples.

Responsible for pulling parts from the warehouse and seeing that line production workers have the raw materials they need to perform their jobs. Obtains parts from the warehouse for use in production and verifies the part's lot number to ensure that the proper materials are used. Pulls supplies for assembly workers and ensures that supplies are stocked and readily available for assembly workers.

Performs routine technical tasks including assembling or constructing simple or standard equipment or parts in an injection molding environment, and may service or repair simple instruments or equipment. Prepares test specimens, adjusts and operates equipment, and records test data, pointing out deviations resulting from equipment malfunction or observational errors. Extracts engineering data from various prescribed sources and processes the data following well-defined methods, then presents the data in prescribed form.

Performs a variety of medical assembly and processing tasks as a production team member. Assembles medical products on an assembly operation, performing a variety of tasks on a rotating basis. Performs on-line and in-process visual inspection of products to ensure specifications per work order and procedure are followed. Assists Team Leader and Technicians with product and/or machine change-overs

The individual will be involved with people and processes associated with various aspects of Supplier Management and Procurement at Merz. The successful candidate will implement the supplier selection and approval process; manage existing suppliers; place purchase orders (PO’s); evaluating supplier performance; resolve delivery issues; assess and reduce supply chain risk; save money by reducing TCO (total cost of ownership).

A Research Associate is responsible for independently designing and executing experiments and analyzing the resulting data in support of reagent and assay development projects. This is a laboratory based position performing protein-based immunoassays on a routine basis with relatively high throughput (3-10 plates per day). The incumbent is expected to display a wide-degree of latitude, creativity and self-management.

The Customer Service Representative I will provide professional, courteous, customer-centric service to the MSD customer base. This individual will directly interact with various customers and interface with multiple internal departments to facilitate the processing of quotes, orders and customer requests to allow for timely shipping of MSD products worldwide.

A Research Associate is responsible for independently designing and executing experiments and analyzing the resulting data in support of reagent and assay development projects. This is a laboratory based position performing protein-based immunoassays on a routine basis with relatively high throughput (3-10 plates per day). The incumbent is expected to display a wide-degree of latitude, creativity and self-management.

The main duties of the Quality Assurance (QA) Assistant are to ensure timeliness of testing, meeting client requirements and providing a safe work environment for employees. The QA Assistant must provide services that are compliant to the ALG-West Quality Manual, client requirements and regulatory requirements as applicable, including ISO/IEC 17025:2017, USP, EU, GLP, GMP, FDA and ICH guidelines.

We are looking for highly motivated QC Associates (two openings) to join our quality team. These positions are responsible for participating as team members in a laboratory environment for finished product/or development programs focused on the goal of testing and releasing the immunoassays found in Micropoint's in-vitro diagnostic products for point-of-care (POC) testing.

We are seeking an experienced individual who has coordinated the implementation of clinical research protocols. 1-3 years of clinical research experience and CCRC certification is preferred for this full-time position.

This role is responsible for all EH&S and Material Management functions at the Novato facility.  This includes but is not limited to managing raw materials coming in to the facility, movement throughout the facility, waste management, and emergency equipment inspection.  Responds to all EH&S requests at the Novato facility.  Organizes all hazardous waste and interfaces with hazardous waste contractor for waste disposal.  Performs all safety inspections throughout the Novato facility.  Documents all inspection finding and informs functional manager of pertinent findings. Acts as the Facility Operations liaison when necessary.

This entry-level position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensure aseptic and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective and professional behavior is displayed at all times. In conjunction with Production Management the Manufacturing Team provides input and assistance to other Departments as needed, playing a critical role in maintaining production schedules and meeting Company goals. The Team Member will be able to participate in all aspects of the Equipment Process. The Equipment Process includes cleaning, assembling, and sterilizing small and large pieces of equipment in accordance with established production records in a concerted effort to manufacture sterile liquid pharmaceuticals.

This entry level position is a member of the Formulation Team, who comprise a portion of the Manufacturing Team. This position will be expected to execute the required responsibilities and tasks necessary to perform as a Compounder I using current Good Manufacturing Practices (cGMP) according to approved SOPs in order to support the overall mission of the Manufacturing Team. 

The full-time Lab Technician will join an essential team involved in our development of oral antibody-based therapeutics. The team member will be expected to execute leading edge molecular biology protocols, support the construction of novel cyanobacteria strains, and aid in the continued development of protocols that have made Lumen Bioscience the worldwide leader in Spirulina genetic engineering. The position requires strong organizational skills to meet quality and productivity goals. Effective communication skills are also crucial in coordinating with other members of the team, providing status updates, and raising quality or trouble shooting issues as they may arise.

The Logistics Coordinator I performs a variety of shipping, stockroom, and receiving tasks. This coordinator prepares items for shipment ensuring cost effective courier services and compliance to global trade, OSHA, DOT and other regulations. Must have a high regard for compliance, attention to detail, and inventory accuracy. Responsible for material transactions within ERP System. Compares information on packing slip with purchase order to verify accuracy; Also includes reverse logistics support.

The Research Associate In Vitro Screening and Biochemistry will contribute to the identification and development of novel small-molecule drugs and support Lundbeck’s CNS discovery programs. The successful candidate will work in multidisciplinary teams to discover new therapeutics, collaborating with biologists and medicinal chemists to select molecules for further in vitro characterization and to identify trends in structure-activity relationships.

Evaluate the function of native and engineered lung tissues and assist with implementation of new analytical regimes to characterize the function of the engineered lung tissues. Assist with data collection and analysis in support of these objectives. Contribute to preparation of human and non-human organs and tissues for experimentation. Prepare specific supplies and materials for designated testing, including design and construction of tubing circuits, preparation of perfusate, and maintenance of equipment used for functional assessment experiments.

Lygos is seeking an analytical chemistry research associate candidate to set up, run, clean, and maintain HPLC instruments. The successful candidate will have experience with general lab procedures, data interpretation, and reporting in a fast-paced and dynamic work environment. Execute analytical methods including: sample, standard, and mobile phase preparation, HPLC operation, HPLC calibration, data analysis, and data entry. Collaborate with the metabolic engineering team, fermentation team, and downstream processing team to ensure that results and conclusions are communicated clearly.

Conducts sampling of incoming raw materials, product environments, and/or facility clean utilities, as per approved procedures and submits these samples to the appropriate testing facility for documented and controlled results. Applies material / system status labels, as indicative of testing status and/or results obtained. Assists with lab maintenance and inventory.

This position provides QA support in the manufacturing of clinical and commercial drug products/medical devices to ensure compliance with the principles and guidelines of cGMP. QA Associates maintain the quality systems, such as laboratory control, investigation management, materials management, document control and training to ensure control of the manufacturing process. This position will actively partner with Manufacturing Operations, Facilities, Materials Management, and other supporting departments to provide compliance and technical guidance to ensure quality issues are identified and resolved in a timely manner.

This position is responsible for performing a variety of tasks in support of all manufacturing activities in accordance with current GMPs. Executes basic manufacturing procedures (cleaning, solution prep, equipment prep) under direct supervision. Accurately follows and completes required documentation (batch records, forms, Quality system documentation) under direct supervision. Expected to adhere to all procedures, including gowning and safety requirements, at all times. Supports manufacturing activities outside of core hours under direct supervision.

Performs basic preventative maintenance activities and repairs to buildings and facilities including; office areas, pharmaceutical manufacturing and processing areas, laboratories, warehouse areas, loading docks, and parking lots and driveways.  May perform maintenance or simple repairs to selected types of plant equipment or systems for which mechanic has received training on.  Works with various types of construction materials used for construction and finishing of walls, ceilings, and floors. Works under the supervision of the Facilities Maintenance Supervisor or, a more highly-skilled mechanic.

The Quality Assurance Technician II performs a variety of review processes with the intent to correct record errors in manufacturing process documentation that includes batch record review and documentation issue resolution.  This role is also responsible for return good inspections, cGMP area inspections and product inspections.  This role ensures QA compliance and that cGMP principles are adhered to.

Performs preventative maintenance activities on specific pharmaceutical manufacturing and/or packaging equipment and systems. Provides maintenance support to manufacturing personnel during the operation of manufacturing and packaging equipment and systems.  Diagnoses problems and performs repairs on manufacturing and packaging equipment. 

Mammoth is seeking a Research Associate experienced in nucleic acid and protein biochemistry techniques to support our product development team. The ideal candidate will have experience with assay development and product commercialization related to molecular tests and reagent kits. The candidate will be comfortable working as part of a team, be highly motivated, and display excellent time management skills. The Research Associate will report directly to Director of Assay Development.

The Enterprise Support Engineer (TSE) provides in depth, high-level technical support to MasterControl customers. The ESE II maintains systems-level expertise and root cause-level troubleshooting while resolving advanced technical issues for customers. ESE II's work with fellow team members, service consultants, sales operations and other company resources to increase customer satisfaction and loyalty. TSE's are responsible for special projects, and will maintain one or more team projects that track team analytics and team success. TSE's will be subject matter experts (SME) in one or more subjects pertaining to the support of MasterControl Customers.

The Specimen Accessioner I performs all paperwork and non-technical procedures required to prepare, process, and submit specimens to the laboratory for testing.  Responsibilities will include but not limited to: receiving, triaging and accessioning patient samples, distribution of patient reports and specimens to clients, performing quality control of accessions and labeling. 

Review data from Cardiac monitors to provide physicians with results to help determine treatment for patients.  This position requires a strong ability to read and interpret EKG strips as well as communicate with Doctors, patients, and other departments throughout the organization. This is a 24/7 facility and shifts are scheduled with differential available for 2nd, 3rd and weekend shifts.

This marketer will drive direct targeted marketing for our platform and solutions by developing programs that leverage outbound marketing efforts - across online/digital and tele-prospecting tactics - to drive overall preference, satisfaction, technology adoption of our platform/portfolio and amplify market impact of our technology innovation stories. Assist and lead in the development of outbound marketing programs across a variety of product offerings, industries, segments, and personas (e.g., Clinical Ops, Data Management, Finance, IT).

The Sr. Contract Operations Analyst is responsible for working with internal/external customers on all aspects of Market Access; Master Data, Contracting, Membership, Chargebacks and Rebates.  They are responsible for the receipt, analysis, impact, resolution and posting/reporting of all contractual payments across multiple customer segments including Health Plans, GPOs, Specialty Pharmacies, Physicians and Wholesalers as well as maintaining all related documentation for those payments.  The Sr. Contract Operations Analyst is responsible for developing Market Access contracts including: template development, strategy interpretation, language negotiation, approval, and execution In this role, they will manage and meet deliverables of business operations to monitor, evaluate and administer claims to be paid and ensure payments are accurate, timely, formulary compliant and entered in contract systems consistent with agreement terms, following corporate controls/approved guidelines and SOX regulations.

At AstraZeneca as the Research Animal Technician I, you will support oncology using basic technical skills such as performing daily health/mortality checks, evaluating health status of animals and performing basic technical procedures such as SC, and IP injections, cardiac blood collection, and oral gavage. Observe appropriate safety and study requirements by reading, understanding and following Standard Operating Procedures (LAR Guidelines), applicable regulations and study protocols. Observe appropriate safety and health practices including personal protective equipment and barrier requirements.

Sampling of the Utilities Systems (for example WFI, Specialty Gases, Compressed Air, Steam). Sample management activities including receipt, visual inspection for integrity, storage, distribution and disposal. Parts and glassware washing and autoclaving, including proper documentation of these activities. Detailed supervision and detailed instructions given for routine work as well as any new activities or special assignments.

The junior microbiologist will assure to support the “in vitro” test according to EN/ISO Standards requirements. Respecting the deadlines; Check the expiration date of the reagents and the microbial strains; Fill laboratory notebooks and record the results. Ability of preparation of culture media and microbial strains suspension. They will report to local manager.

Our successful Clinical Research Associates possess various backgrounds in medical and other science-related healthcare fields. This role takes you on a journey through travel and excitement which will allow you to make a difference on a large scale through the enhancement of pharmaceuticals and medical devices. No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE Training Program, you will join other Professionals Achieving CRA Excellence: PACE provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA.

You will be part of a small and nimble team that conceptualizes, develops, and proves-out designs that make an impact on the world of medicine. Your primary role is driving conceptualization, development, and prototyping of new product concepts, focused on inventive uses of new and existing technologies that open up entirely new product concepts. Work hours and days are extremely flexible, based on need and your availability.

We are seeking a talented and highly motivated individual to join our multi-disciplinary team as a Research Associate. This individual will be a key contributor to executing reagent formulation activities including technology transfer, process development, analytical method development, verification and validation. The position will be located in Lexington, MA. Responsibilities: Development, optimization, scale up, and validation of reagent processes and measurement systems; including DOE and capability analysis. Experimental planning, execution, and data analysis. etc.

The candidate will join the Assay Development group in the R&D division where focus is on molecular assays development such as nucleic acid isolation, purification, amplification and labeling technologies. We are seeking talented, motivated individuals to join a collaborative effort to enable development of rapid diagnostic tests of several pathogens from various clinical specimens. Position Responsibilities: Work with senior scientists and run hands-on experiments for microbiology, sample preparation, nucleic acid extraction and amplification. Participate in design of molecular assays. etc.

We are seeking an innovative, collaborative and enthusiastic immunologist to work on building our immunology and Immuno-Oncology Programs. This individual will work primarily at the bench to help drive target identification, validation, and patient selection strategies. Job Responsibilities: Culture and engineer primary human T cells and murine T cells using genetic tools. Culture and engineer primary human tumor cell lines and murine cell lines using genetic tools. etc.

Responsibilities: Generation and maintenance of various cell lines and used by internal research groups. Production of retroviral vector stocks using various transfection methodologies. Assist analytics team in evaluation of in-process and endpoint samples. Thorough documentation of procedures and experiments. Coordinate with various internal groups for the generation and evaluation of emerging vector products. Assist in drafting of SOPs, technical documents, batch records, etc, for transfer to external CMOs. Participation in internal and external meetings detailing ongoing work. etc.

TechLab, Inc. develops, manufactures and distributes medical diagnostic tests. Our company places emphasis on science and collaboration with Universities. We are hiringa Research TechnicianforourScientific Affairs teams.The Research Technicianwill aidthe team with experiments and research. The Research Technician can be expected to perform protein purification using chromatography, write Standard Operating Procedures and Master Batch Records, and assist with assay development and optimization. etc.

Responsibilities: Building and maintaining relationships with physicians and office staff to drive clinical orders in the community. Building and maintaining relationships with pathology departments to ensure smooth specimen sendouts - tissue procurement. Maintain a regular cadence of touch points (in person, emailing value adds) with certain targeted accounts (ie 3 x month per physician). Coordinating Medical Affairs report review with physicians after clinical orders. Order Kit and literature replenishment at accounts. Identifying and attending approved local conferences. Working with accounts to obtain necessary clinical data / progress notes for Tempus-tested patients. etc.

What you’ll do: Work with a cutting-edge genomics workflow to provide high-quality next-generation sequencing data with rapid turnaround times in a clinical laboratory. Utilize automation and robotics to standardize the discovery pipeline from sample acquisition to sequencing output. Maintain quality metrics and data generation for next-generation sequencing platforms. Work to maintain CLIA/CAP compliance in a novel field. Work our daytime shift Monday - Friday.

TeVido BioDevices is seeking a highly motivated individual to join our team as a Biotech Manufacturing Technician. We are a small Austin, TX-based biotech company that is addressing unmet needs in reconstructive and cosmetic surgery. The company has launched the manufacturing of our first product, cellular grafts, to treat patients with skin pigmentation disorders such as vitiligo. The person in this role will be responsible for performing daily production operations, including processing, quality control tests, and production facility cleaning; documenting work; and aiding improvement projects. This individual should be detail-oriented and self-motivated. An Associate’s degree in biological sciences or bioengineering and experience with aseptic technique in a laboratory or cleanroom is required. This is a challenging and exciting opportunity to contribute to an innovative, fast-paced startup in Austin, TX whose mission is to enhance patients’ quality of life using their own tissue. etc.

How will you make an impact? Sets-up, operates, and maintains the classified environments and manufacturing equipment for pharmaceutical products. Ensures operations are performed in a safe and responsible manner striving to create an injury-free and incident free workplace. What will you do? Operation of aseptic filling, freeze drying and capping equipment. Ensures pharmaceutical products in manufacturing are in accordance to SOPs and current GMP and other batch related activities. Verifies and documents production activities in batch records, logbooks, etc. Assists in troubleshooting operational and production problems in order to identify appropriate corrective actions. Performs the disassembly, assembly, cleaning, and operation of area manufacturing equipment. etc.

The QA Associate will participate in the day to day operations related to release functions in the Quality Assurance Department. The incumbent is responsible for the timely review and disposition of controlled materials needed to support manufacturing. These materials include, but are not limited to, sterile supplies, cell banks, viral banks, and reagents used by manufacturing or for testing processes. The associate identifies areas for improvement and ensures materials, products, and equipment within the warehouse remain in a state of control. etc.

Responsibilities: Testing of raw materials, finished product, and stability samples while meeting deadlines and following an assigned schedule. Accurately documenting all tests/test materials/equipment used and all results obtained. Work in accordance with approved methods, SOPs, and cGMPs/GLPs, while performing tests. Responsible for safety and to protect themselves and fellow employees from harm.

Responsible for all quality control aspects of finished product testing. Ensure that performance of finished product is in compliance with testing standards per IFU and SOP's in addition to customer requirements and regulating agencies' guidelines. Documentation control duties per Quality assurance compliance requirements. Key Responsibilities: Review and maintain product compliance specifications, documentation control. Gain proficiency on all performance benches. Documentation of testing results and determining disposition. Maintain consistency in training in Master Control. Establish and maintain SOP criteria for inspection/testing. Responsible for maintaining department equipment and requesting consumables as needed. etc.

Invenra is seeking a highly motivated laboratory support technician. This individual will maintain the laboratory and laboratory supplies in a clean, ready and working order. The position will work collaboratively with others to implement process improvements that increase efficiency and quality in the laboratory. This is a part-time position.

The Histology Technician works in the laboratory to perform and support ex vivo studies including, but not limited to, histology, autoradiography, 3D fluorescence imaging, and cell culture. The ideal candidate will have hands-on experience in a pharmaceutical histology laboratory performing standard histology studies – embedding, sectioning and chromagen/fluorescent antibody staining. In addition, the ideal candidate will have a proven track record and competence in histology or autoradiography method development. The individual in this role will be expected to understand and carry out analysis to inform his/her own development efforts and assist in-house analysts.

The Distillation technician supports the Operations Manager and Production Supervisor in achieving daily production targets prioritized by Safety, Quality, Delivery and Cost. Following the priorities set by the Manager and Supervisor ensures that distillation columns are operating safely per procedures and to meet daily production goals laid out by supply chain.

This position is focused on service delivery excellence for UnityTM Lab Services. Specific activities relative to the job function could include: laboratory glassware and inventory management. This position will utilize the basic functionality of systems and equipment relevant to the job function, such as: industrial glasswasher, sterilizers, and ovens. Strong communication skills are also required

Conducts routine chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods. Executes validated test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, LC/MS, dissolution, spectroscopy, and/or traditional wet chemical testing. Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems. Performs daily instrument calibrations / verifications as required.

Operate processing and packaging equipment. Equipment includes: balances, labelers, band sealers, pumps, filtration systems, and other packaging equipment. Weigh, measure and check raw materials with assistance of computer interface to assure batches manufactured contain proper materials and quantities. Calibrate/operate semi-automated and automated manufacturing equipment. Complete and maintain Quality Records in compliance with regulatory requirements, GMP’s and standard operating procedures.

As a Development Associate I/II at Invivoscribe you are responsible for generating and documenting laboratory data with direct supervision. Your performance will contribute to a quality data generation in a regulated environment following good laboratory practices. More specifically: Support development projects that can include generating analytical data for an FDA submission. Use laboratory techniques such as PCR, gel and capillary electrophoresis, aseptic technique for mammalian cell culture, magnetic beads purification, DNA quantification and NGS. Execute and document experiments that support the development of diagnostic reagents and assays. Experimental design will include all of the appropriate controls.

As a Entry Level Sales Executive, you will be responsible for maintaining and growing a client base of both hospital and physician customers for MDL. Responsible for achieving annual sales and profit objectives for a defined territory. Obtain new business and exceed annual territory sales budget each year by presenting new test information, up selling and seeking out new sources of revenues from clients. Develop and present personalized sales presentations to professional audiences (physicians, laboratory staff, clinics and group practices); demonstrate how MDL's technical features and services could benefit the practice and help medical personnel provide quality patient care.

We are seeking a motivated and talented Research Associate to develop and perform in vivo and in vitro bioassays on mice and rats. The Research Associate should have excellent skills in basic rodent procedures. Rodent surgery skills are a plus. Experience with biochemical and tissue culture techniques is a plus. Excellent communication and computer skills and motivation to learn new assays are essential. Ability to work in a highly interactive and multidisciplinary team environment.  

The Drug Safety Associate candidate works in a team-oriented, dynamic, and collaborative environment. This person would manage the drug safety mailbox, track case workflow, support the drug safety team, review serious/adverse event information, and review case narratives.

Provides internal oversight and conducts the day to day running of a project throughout its life at Q2 Solutions, including method development, method validation, and sample analysis while adhering to timelines, SOPs and performance metric standards. Serves as internal liaison between the production lab scientists and project management team. Provides daily direction and feedback to laboratory staff regarding Vaccines studies. Effectively and efficiently coordinates and communicates with relevant internal support groups as needed for the study.

Develop superior product and disease state knowledge and effectively educate and engage healthcare professionals in dialogue about clinical evidence, approved indications, and product efficacy/safety profiles to support on-label prescribing for appropriate patients. Representative must demonstrate a strong understanding of relevant disease states and possess a solid ability to communicate necessary technical, scientific, and product and disease management information to customers. Drive sales performance in a compliant manner and work to meet or exceed territory sales goals through execution of regional and national marketing strategies

We are hiring for a Powder Formulation Tech. The Powder Formulation Tech is responsible for the formulation of our company’s powder cell culture media products. NOTE: The current opening is on our second shift (1:00 PM – 9:30 PM). Formulates Powder media formulas per manufacturing protocols utilizing various weighing equipment such as scales and balance. Uses Mettler-Toledo IND780 terminal system to ensure correct raw materials assigned in the batch record are used and at the specified quantity. Reviews lot folders for accuracy, completeness and availability of components necessary to complete job prior to the scheduled date of production

The Environmental Monitoring (EM) Technician IV is required to perform the basic functions associated with environmental monitoring. Incumbents are required to learn the laboratory functions, sanitization procedures, and donning scrubs for ISO 8 sampling requirements. Sampling, initiating tests and collecting test results related to defined quality parameters for surface, air, product and utility systems such as compressed gases and WFI.

The successful candidates will have some experience in one or more of the following areas including chromatography, filtration, electrophoresis, analytical chemistry, cell culture and/or bioreactor operations. Experience with high throughput, robotic techniques for analytical testing, chromatography, and/or protein expression, as well as statistical design of experiments and/or process modeling, is a plus. The ideal candidate has strong written and verbal communications skills and works well independently and in teams. This position may include the opportunity to rotate through different functional areas to gain experience in different techniques and disciplines.

Assist in the development of client deliverables according to project requirements, including but not limited to, project-specific documentation, operating procedures, and work flows with direction of more experienced staff. Process incoming and outgoing project materials to monitor, verify, and track receipt of documentation and ensure appropriate distribution of materials to internal and external research personnel and sites. Prepare general correspondence, agendas and meeting minutes, reports, and other project-specific documentation. Ensure review, approval, and distribution to internal staff and external project participants.

Responsible for a wide variety of cell-related functions, including producing cells, intermediate product, and manufacturing final product for commercial distribution. Follow SOPs, perform daily tasks in a clean-room, retain records and write reports. May also be responsible for troubleshooting. Assist in execution of procedures for cell culture manufacturing, purification, or support area of manufacturing using SOP’s and batch records. Responsible for various duties that are required to produce product including but not limited to cell expansion; cell feeding, harvesting, counting and freezing; product seeding; growth system maintenance; labeling, packaging and freezing of product; and culture media preparation. Follow specific techniques and operations while demonstrating an understanding of cGMPs and how they apply to specific responsibilities.

The successful candidate will apply scientific and engineering principles to support new biopharmaceutical process enrollments into the cGMP manufacturing facility. The candidate will: Perform all aspects of facility fit activities to support program enrollment including generating process flow diagrams, bill of materials (BOM), new specifications, and Äkta chromatography methods. Collaborate with process development and manufacturing teams to perform technical transfer and facility fit activities for downstream processes.

This position is for a 2-week cycle, day shift with every other weekend off. Coordinate and perform cGMP manufacturing operations for biopharmaceutical products. Ensure the effective use of material, equipment and personnel while making products with the highest quality.Assist in execution of procedures for microbial manufacturing, purification, or support area of manufacturing using SOP's and batch record. Responsible for completing paperwork for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and laboratory safety practices and procedures.

Keystone Nano is looking for a Research Chemist able to play an important role in developing novel drug products for cancer applications. The successful candidate will join our laboratory in State College, PA to conduct chemical and physical experiments using our proprietary manufacturing techniques to develop and scale this technology for a variety of markets. Set up and conduct chemical experiments, tests, and analyses using techniques such as spectroscopy, chromatography, physical and chemical extractions, dynamic and quasi-electric light scattering and microscopy, Compile and interpret results of tests and analyses Prepare graphs and charts to document experimental results for presentation to management.

Validate Bacterial Endotoxin test method and test of finished products with gel clot and kinetic method; Perform and validate anti-microbial effectiveness Testing; Perform Sterility testing and validation using Steritest equinox System for finished products, Aseptic process stimulation; Identify genus level microorganisms using Vitek-2 ID; Perform Environmental Monitoring in aseptic and other controlled areas in ISO-5/6/7/8; Recover Bio burden by Various Microbial enumeration methods; Endotoxin recovery studies, Qualification of Microbiological equipments like Steritest Equniox

Executes the activities of QC Microbiology Laboratory by following approved microbiological and chemical test procedures and ensure their delivery in an accurate and timely manner following proper safety precautions. Also provide QC microbiology support to the Aseptic Manufacturing and validation process.

Perform routine and complex technical procedures and functions according to departmental Standard Operating Procedures. * Monitor, operate and troubleshoot instrumentation (can include specific dept instrumentation) * Demonstrate the ability to make technical decisions regarding testing and problem solving. * Able to resolve technical, computer, and customer service problems within the specified department. * Deliver quality patient care while maintaining efficiency. * Perform preventive maintenance and quality control with appropriate documentation and communication. * Assist in processing of specimens when needed.

The position will receive samples and prepare them for analysis via plating, centrifugation, gram stain preparation and maintenance of instrumentation.This position will include repetitive motion and extended time on feet, and also includes handling of biological samples (Urine, stool, bacterial swabs, sputum, body fluids). Prior experience handling samples preferred.

The employee will be responsible for executing projects within the laboratory, writing study/research plans, and summarizing data to clients and colleagues via technical reports. The position requires a drive to provide outstanding customer service by maintaining regular communications with clients, meeting or exceeding quality and timeline expectations.  

We are seeking individuals who arepassionate about research, bringout of the box thinking and take bold steps todevelopinnovativetechnologies with applications in the ubiquitin research field.Successful candidates will have basic knowledge of biochemistry and molecular biology techniques, in particular experience with, protein expression andpurification and cloning. Knowledge of the ubiquitin proteasome pathwayis desired.

The Clinical Research Associate in collaboration with the Clinical Trial Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs/WPs.  Responsibilities may include participation on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors.

This position is responsible for designing new assembly tooling and assembly fixtures for product assembly. The position also requires designing tooling and solutions for specific tests and departments as requested. All tools/solutions must meet quality and manufacturing specifications provided by standards and the customer. Approach and Deployment: Design tools for production and specialty use. Utilize CREO to create accurate component, assembly and system models and drawings. Ensure designs meet performance, manufacturing, quality, cost and design requirements. Coordinate and lead design reviews as required. etc.

Supports lead biostatistician on clinical studies; may serve as lead biostatistician with oversight from a more senior biostatistician. Maintains the statistical integrity of clinical trials analyzed by SDC. Assists in preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, and writing statistical sections of clinical study reports. etc.

Stellartech is looking for a Quality Engineer to join our Team. Responsibilities: Perform quality engineering development activities for new product designs by assisting Engineering in the preparation of design and development plans, Design History File documentation, and Design History File preparation. Review and approve Device Master Record documentation for new product design and maintenance, including: bills of material, assembly procedures, manufacturing operations, assembly diagrams, test procedures, component specifications, labeling, and operator’s manuals. etc.

Provide on site and remote service and support of Stereotaxis magnetic navigation systems including permanent magnets, and servo control systems. Interface with customers and vendors to ensure a quality service experience and that all expectations are met. ESSENTIAL JOB RESPONSIBILITIES: Interface with customers to obtain accurate details of the equipment service needs and provide updates regarding the progress of the service/installation. Diagnose and repair control servo control systems. etc.

This position operates production equipment, to include non-sterile filling machines, and packaging and labeling machines. Position is responsible to supply assigned positions with materials/items to complete work and according to standard operating procedures. Position is also responsible to clean equipment, production areas, and inspect parts/items following prescribed procedures. Provides troubleshooting on basic issues and may assist in providing training. etc.

This position operates production equipment, to include non-sterile filling machines, and packaging and labeling machines. Position is responsible to supply assigned positions with materials/items to complete work and according to standard operating procedures. Position is also responsible to clean equipment, production areas, and inspect parts/items following prescribed procedures. Provides troubleshooting on basic issues and may assist in providing training. etc.

This position is responsible for the maintenance and efficient operation of production/manufacturing equipment for pharmaceutical operations. Position also responsible to perform both maintenance and preventative maintenance, and repair work to production equipment as needed. Provides troubleshooting on rudimentary issues and seeks guidance as part of an escalation process. How you make a difference . . . you will . . . Performs maintenance work, to include equipment repair and preventative maintenance work as required or assigned. Performs the repair and maintenance of APA area floors and walls. Completes work orders and projects as assigned, supporting each team member as directed. etc.

Position acts as Trusted Advisor to STERIS Customers in maintenance and procurement of medical devices and consumable products as part of a high performing team. Drive an exceptional Customer experience by providing on-site preventative maintenance, troubleshooting, repair, equipment modification and installation support on complex mechanical, electro-mechanical and electronic units in a high stress healthcare environment. Provide superior Customer service by pro-actively interacting and communicating with Customers. Utilize advanced technology to complete administrative requirements, aid in troubleshooting issues and improve the overall Customer experience. Promote STERIS growth through identifying and recommending products and services to Customers. etc.

Provides on-site support for the reprocessing of surgical instruments and trays to contracted facilities in compliance with the Department of Health, TJC, OSHA, CDC, AAMI and AORN standards and facilities goals and policies. Position level will be determined by previous job related experience, performance and certification requirements. Duties: Operates all mechanical machinery; cart washers, instrument washers, steam sterilizers, low temp sterilizers, ultrasonic and drying cabinets, within sterile processing. Uses established policies and procedures to complete work assignments. Learns and trains in all areas of sterile processing including decontamination, cleaning, assembly, wrapping, sterilization, and storage processes within all set professional standards and regulations. etc.

Install operating room integration equipment as directed by Integration Specialist (I and/or II) and/or Integration Project Manager. Perform preventative maintenance, troubleshooting, repair, equipment modifications, and installation on all integration equipment serviced by STERIS. Help drive STERIS initiatives for growth and development of business. Interact with customers in a professional and knowledgeable basis. Complete administrative requirements as required. Duties: Help install operating room integration systems. This includes physical placement of equipment, installation, termination and interconnection of all cables, downloading and configuration of software; and testing of all functions per test documentation as required. etc.

Caliber Ophthalmics is currently seeking a Surgical Sales Representative to be based in Florida. As a valued employee at Caliber, you will enjoy a total benefits package including competitive salary, medical/dental/vision/life insurance, short-and long-termdisability, 401k, and more. The Surgical Sales Representative is responsible for managing the Floridasales territory, working directly with surgeons for the sale and promotion of our Caliber Ophthalmic portfolio of surgical device products to include our disposable knives, suture, and other microsurgical products. Target call points are hospitals and ambulatory surgery centers. In this surgical sales role, you will be responsible for maintaining and growing annual sales volume in Florida.

The QC Data Review Specialist will be responsible for GMP review and comment on laboratory raw data, procedures and reports to ensure methods, protocols and other procedures were properly followed, results are analytically accurate and correct, and that all documentation meets GMP standards. ​Responsibilities: Review of documentation generated during method validation, method verification, stability testing, routine testing and other analyses. Review documentation, results and reports from raw material and finished product analysis for accuracy and completeness. etc.

The Pharmaceutical Sciences group at Seattle Genetics is seeking a highly motivated research associate to support development of therapeutic antibody-drug conjugates. This person will play a critical role in the formulation and drug product process development of a novel pre-clinical ADC. The ideal candidate will have working knowledge of biologics formulation development and experience in common analytical techniques, as well as strong critical thinking skills and the ability to design, execute, and draw conclusions from experimental studies with managerial guidance. The ideal candidate should have a background in formulation development or analytical biochemistry or a related discipline, good interpersonal skills, and an ability to work effectively in intra-departmental teams to achieve program goals.

The position will hold responsibility for assisting in the manufacturing of Sedia’s immunoassay product lines encompassing lateral flow and ELISA test. The holder of this position is expected to follow the guidance of their direct supervisor to assist in delivering company products in a timely and cost effective manner. The position will contribute in building product subassemblies or final assemblies. The Manufacturing Technician will adhere to all applicable regulations, policies, and procedures for health, safety, and environmental compliance. etc.

As a Bioinformatics Support Engineer you will be exposed to a wide range of translational applications and will work and learn from experts spanning numerous disciplines from informatics through cloud optimization and clinical data. You will work back to back with various members of our support and bioinformatics teams, helping our clients overcome obstacles they encounter. You will diagnose, resolve and explain issues and questions raised by our clients. Main responsibilities: Understand each client’s use case and their bioinformatics data processing pipelines. Debug, troubleshoot and resolve client issues associated with bioinformatics tools on the Seven Bridges platform. etc.

Silicon Therapeutics is seeking a highly motivated Research Associate, Machine Learning who wants to work in a multi-disciplinary organization with the aim of treating challenging diseases. Job Responsibilities: Work with a multi-disciplinary team (e.g. chemists, biologists, biophysicists) to discover novel medicines for challenging disease targets. Apply machine learning techniques to real-world drug discovery problems. Develop methods to improve the robustness of predictions from molecular dynamics simulations and quantify uncertainties associated with free energy simulations. Build state of the art machine learning infrastructure and workflows for molecular design. Work closely with bench scientists to understand critical project bottlenecks and how machine learning can help.

The Systems Engineer will be responsible for supporting every phase of the product development life cycle process in order to deliver high-quality products in the consumer and medical device markets. The Systems Engineer will work with the electrical, software, mechanical, product technical support, and quality teams to help develop, integrate, and test sub-assemblies into product. The ideal candidate has broad skills but deep knowledge/skills in one area, and is able to blend human-centric design with sound engineering principles across a wide range of engineering domains with a focus on quality and willingness to wear many hats. etc.

The Quality Assurance Inspector 1 shall be responsible for performing basic visual/dimensional/functional inspections of incoming purchased product as well as product manufactured/assembled in-house, determining whether or not product meets specifications and documenting these decisions. Essential Responsibilities: Inspect raw materials, components, assembled product, semi-finished product & finished product per inspection procedures/drawings and to print specifications. Utilize attribute and variable measuring equipment/gauges as well as mating parts to determine as found/as left conditions of product. Support the qualification/validation processes for company product. etc.

Support, and sustain elements of Smith & Nephew’s quality system through procedure generation, training, auditing, and technical support. Leading and supporting quality project initiatives. This position provides support and services in CAPA, complaints, validations, audits, quality holds, calibration and various other requirements of the medical device (US & International) regulations for R&D, Process Engineering, Manufacturing, Quality, and Regulatory plus any quality system support required. etc.

Reporting to the Solid Quality Control (QC) Unit, the QC Associate is responsible for day to day operations related to sample submission and data management in support of QC GMP and cross-functional development. The candidate will maintain documentation in accordance with internal data entry, analysis and trending SOPs. In addition, coordinate domestic and international biologic sample shipments (at room temperature, on dry ice, or in liquid nitrogen) according to applicable guidelines. etc.

We are currently seeking a Downstream Manufacturing Associate I. This position is tasked with supporting all aspects of downstream manufacturing processes. For GMP-qualified campaigns this involves large scale buffer preparation, column chromatography using the Akta Process system and large bed volume columns, various filtration methods, ultrafiltration/diafiltration methods, and formulation. This position will also be responsible for supporting the inventory control for the downstream group. etc.

Responsibilities: Provide support to the Clinical Trial Managers and Clinical Research Associates in clinical trial conduct via preparation, distribution, and tracking of study supplies, mass mailings, copying, data entry, etc. Demonstrate superior communication and organizational skills in addition to the technical skills required for overseeing clinical studies. Recognize the urgency of meeting established schedules and be able to prioritize tasks and time to meet those schedules. Help manage and report on the conduct of clinical studies, as directed. Help identify and select trial sites. Conduct qualification, initiation, interim monitoring close-out visits, and perform drug accountability (approximately 25% travel required). etc.

This unique opportunity is designed for individuals with a Bachelor's Degree in Life Sciences, strong organizational skills, excellent written and verbal communication, and working knowledge of computer systems including Microsoft Word, Excel, Outlook, and PowerPoint. ICON, a leading Clinical Research Organization, is seeking passionate, resilient and inspiring Graduates to join our team as a Clinical Trial Assistant. This opportunity offers an entry-level permanent position to highly skilled individuals interested in a career in clinical research.

As a Laboratory Assistant will assist and aid the technical staff with handling and accounting for biological lab specimens, reagent inventory, and any other relevant tasks. Assists with retrieval and set up of samples for analysis. Receives samples from Sample Management and segregate and distribute to the lab as per standard operating procedure. Monitor Sample Logistic Scan/pending list and search for lost samples. Troubleshoot issues with Sample Management when required. Member of the Lost sample Team.

Our Configuration & QC Specialist plays a key role within ICON Laboratory Services (ILS). Support the Project Management Team (PM) in configuring and QC'ing new studies in all ILS systems according to the specifications of the Client Laboratory Worksheet (CLW) and create all supporting documents and site instructions to facilitate proper specimen collection, packaging and shipping, including visit requisitions, reference range tables and study specific Lab Manuals.

Our Configuration & QC Specialist plays a key role within ICON Laboratory Services (ILS). Support the Project Management Team (PM) in configuring and QC'ing new studies in all ILS systems according to the specifications of the Client Laboratory Worksheet (CLW) and create all supporting documents and site instructions to facilitate proper specimen collection, packaging and shipping, including visit requisitions, reference range tables and study specific Lab Manuals.

The BQ/EQ Scientific Technician I is responsible for performing routine and non-routine testing in support of all aspects of the manufacturing operations including but not limited to the utility systems, sterilizer systems, incoming raw materials, in-process product solutions and final product solutions while adhering to safety, standard operating procedures (SOPs), standard test methods (STMs) and specifications, current good manufacturing practices (cGMP), standard laboratory practices (SLP), current good documentation practices (cGDP) and plant policies/guidelines.

The Sample Management Technician receives and prepares samples for laboratory analyses and tests. Prepares samples on slides or other testing format, records required information and sends to appropriate specialty lab area. May be cross-trained to perform basic Laboratory Technician duties, such as performing less complex tests. May be responsible for various support activities, including maintaining supply inventory, record-keeping, cleaning, clerical tasks, supply shipping and receiving, mail distribution and other related duties. Collects and prepares samples as requested/ required for R&D project teams.

You will be using automated analyzers, microscopes, and other laboratory diagnostic tools to perform analyses and tests that diagnose animal illnesses, injuries, and diseases in support of veterinarian animal treatment. You will be responsible for setting up and running lab tests, and reading and releasing results according to SOPs (Standard Operating Procedures). You can expect to specialize in one or more of the following areas:

Immucor is seeking a Medical Laboratory Technologist to join our Quality Laboratory team. The Medical Laboratory Technologist is responsible for performing laboratory testing (including potency, specificity, reactivity and hemagglutination assays) and chemical evaluations (including protein, absorbance, chloride, osmolality, and pH) of Immucor products according to approved Standard Operating Procedures (SOP’s) within defined timeframes.

Immucor is seeking a Medical Laboratory Technologist to join our Quality Laboratory team. The Medical Laboratory Technologist is responsible for performing laboratory testing (including potency, specificity, reactivity and hemagglutination assays) and chemical evaluations (including protein, absorbance, chloride, osmolality, and pH) of Immucor products according to approved Standard Operating Procedures (SOP’s) within defined timeframes.

The primary purpose of this second shift position is to provide support to the sample management group in a QC laboratory setting in support of commercial manufacturing. Responsibilities of the QC Sample Coordination Technician include collating receipt of samples and coordination of testing, preparation of samples using aseptic technique, organizing and tracking lot release data, submission of samples to contract testing laboratories and tracking sample custody.  Activities include equipment maintenance, coordinating with Shipping and Receiving, and receipt of test results from contract laboratories.

The Production Support Associate is part of our production team. The Production Support Associate supports our production team by assisting in the main production area. Performs various routine production tasks under the guidelines of established SOP’s and CGMP regulations. Prepares components needed for production, such as washing vials, wiping of supplies needed for the clean room. Performs cleaning and disinfecting of manufacturing and clean rooms per established procedures.

The Clinical Specialist is responsible for calling on practicing physicians, hospitals, clinics and other health-related organizations within an assigned territory.  The Clinical Specialist must provide the healthcare professional with the most current information pertaining to Indivior products and their approved indications in a manner which will ensure the appropriate use of these products and achieve the business potential of the territory.  Accomplishments of these goals must comply with the terms and conditions outlined in the Company Policy and Procedure Manual.

Assists with the activities required to manufacture autoimmune diagnostic products by following established procedures. Major duties include the manufacturing of tissue sections and their placement onto glass microscope slides for use in Immunofluorescent Assay products. Participates in all activities associated with the manufacturing of the tissue sections and their placement onto glass microscope slides in accordance with written documentation and established procedures. Manufactures 8.5 eight-well ANA Plus Slides per hour after three months of training. 10 eight-well ANA Plus slides per hour within one year of employment. Thereafter, manufactures 10.5 slides per hour for eight-well slides and 21 slides per hour for four-well slides (all tissue types). Assists with the activities required to manufacture autoimmune diagnostic products by following established procedures. Major duties include the manufacturing of tissue sections and their placement onto glass microscope slides for use in Immunofluorescent Assay products. Participates in all activities associated with the manufacturing of the tissue sections and their placement onto glass microscope slides in accordance with written documentation and established procedures. Manufactures 8.5 eight-well ANA Plus Slides per hour after three months of training. 10 eight-well ANA Plus slides per hour within one year of employment. Thereafter, manufactures 10.5 slides per hour for eight-well slides and 21 slides per hour for four-well slides (all tissue types). Assists with the activities required to manufacture autoimmune diagnostic products by following established procedures. Major duties include the manufacturing of tissue sections and their placement onto glass microscope slides for use in Immunofluorescent Assay products. Participates in all activities associated with the manufacturing of the tissue sections and their placement onto glass microscope slides in accordance with written documentation and established procedures. Manufactures 8.5 eight-well ANA Plus Slides per hour after three months of training. 10 eight-well ANA Plus slides per hour within one year of employment. Thereafter, manufactures 10.5 slides per hour for eight-well slides and 21 slides per hour for four-well slides (all tissue types).

The Assistant, Clinical Trials (CTA) is responsible for supporting, under the direct supervision of the supervisor/Clinical Project Lead (CPL), clinical trial execution, investigator sponsored research and program level activities as assigned within Clinical Operations at Inovio. This position assists in various tasks and projects related to clinical trials as well as basic, administrative duties.

The Inside Sales - OmniPod Associate role is responsible for all patient communication during the sales process of starting patients on the OmniPod system.  This role works closely and collaborates with the field sales and internal team members to provide the best patient experience possible.  This role is responsible for communicating insurance benefit guidelines and cost share information with patients and assists them with their decisions regarding insulin pump therapy.

The Clinical Services Specialist (CSS) is primarily responsible for meeting all clinical initiative expectations.  This responsibility will require extensive travel and extended stays in a field based territory to support open territory needs. The CSS will provide product sales, training, downloading and technical support in accordance with company policy.  They will also in-service physicians, mid-level staff, CDE’s, and ancillary staff on the OmniPod Insulin Management System, build relationships with our customers, and skilled at selling and using the OmniPod Insulin Management System. 

This position is integral to supporting the department through complaint software enhancements, upgrades, report creation, data structure, and validation activities/documentation.  The BA will be the primary connection to IT resources supporting the business unit.  The BA will have a strong understanding of the business unit’s processes, context surrounding why the processes are in place, and what happens if processes are not functioning/followed.  The BA will be an expert in the systems utilized by the business unit and understand the implications of system structure, how changes may impact systems, and how system data is utilized for reporting. 

Initiates, directs and manages the design, development, constructing and modification of products and processes from conception to implementation. Works closely with other departments to coordinate design engineering activities. Reviews, initiates or approves engineering drawings, layouts, changes orders and specifications.

Performs deburr, finishing, and cleaning in a job shop or high volume applications. Processes components to meet print and or geometric tolerance requirements. Responsible for the setup, operation and maintenance of production equipment needed for deburr, finishing, and cleaning operations, maintenance of proper documentation, and support of the manufacturing engineering function. Under close supervision, completes tasks as directed by SOPs, routers, prints, work instructions, and manufacturing schedules.

The accountant position is responsible for performing a combination of cost and general ledger accounting and financial close tasks, as assigned. Perform the monthly financial close process for the local ledger, including preparation of the monthly journal entries and balance sheet (cash, inventory, payables) and P&L account reconciliations, as assigned. Run various reports used to reconcile or analyze general ledger account balances. Assist in the preparation of the standard monthly management reports. Perform detailed monthly variance analysis on items in the P+L and balance sheet.

Our company is in an exciting growth phase where we are launching new products and reaching new markets. To support our growth, we seek a Business Development Associate to help launch new partnerships, businesses, and growth strategies. Successful candidates will also be involved with our marketing and sales teams to assist with strategic growth plans.

We seek a Research Associate I, who will work with a dedicated group of scientists on the development and commercialization of biomedical technologies. Conduct laboratory research and support general R&D efforts for customer-based biomedical research. Projects may involve cell culture, virology, DNA preparation, and liquid-handling automation. Perform cell-based assays (Western blot, ELISA, immunofluorescence, flow cytometry)

To meet the growing demand on the part of our clientele regarding the outsourcing of projects and technologies, we are seeking candidates for the position of Research Associate I or II in Research and Development (R&D). Assemble study designs, perform laboratory experiments, organize data, and analyze results under minimal supervision. Analyzes, records, and reports the results and conclusions for laboratory experiments. Summarizes and interprets data. The candidate should also be open to learn new laboratory techniques and work under the guidance of experienced researchers.

We are seeking a talented Research Associate (level determined by candidate experience), Pilot Plant Operations for our Industrial Products Division (IPD) located in South San Francisco. The Research Associate will be responsible for operating pilot plant equipment, performing maintenance tasks, and have the skill set to thrive in a dynamic team environment.

A Mechanical RMA Repair Technician II works under general direction, follows oral and/or written instructions, and performs repair and testing processes to produce tested electro-mechanical assemblies or associated sub-assemblies. Performs some-what complex tasks in preparation for repair and testing. Is able to verify assembly documentation accuracy, read engineering drawings etc. Sets up and operates machines/equipment /fixtures needed to perform repair and testing processes.

The Associate Scientist, Data Science works within the BioAnalytical Team at Precision Biosciences focused on the development of genome-edited allogeneic CAR-T therapeutics. The incumbent will play a lead role in the identification and implementation of existing and/or novel algorithms, analytical techniques and computational procedures to mine, clean, and interpret a wide variety of data derived from genomic, proteomic, metabolomic, and cellular phenotypic methods. This team member will be a part of our broader CMC organization which aims to drive technical excellence for the successful development of Precision Biosciences’ Cell and Gene Therapy Products, including allogeneic CAR-T cells, AAV viral vectors, and Lipid Nanoparticle-Encapsulated mRNA spanning a broad range of indications in immuno-oncology, infectious disease, and rare genetic disease. etc.

What to expect day-to-day: Generating randomization schedules and providing sample size calculations. Providing input into development of case report forms (CRFs). Authoring and reviewing statistical analysis plans, including development of table and listing shells. Generating analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS. Providing programming support and quality control for SAS Programs and other study documents. etc.

As Research Statistician, you will perform a wide range of activities including: literature reviews; analysis; preparing reports, slide decks and meeting notes; and quality assurance/review. You will independently complete, evidence synthesis projects, including: client management; systematic literature review (SLR); (network) meta-analysis; economic modeling; and dissemination of results. etc.

JOB OBJECTIVE: Perform Quality inspection and analysis activities including: Receiving inspection of purchased components and materials in accordance with written procedures, statistical sampling plans, inspection standards and engineering drawings and specifications, using measuring equipment. In-process and finished device inspection and release activities in accordance with the Device Master Record. etc.

Reporting to a PhD Scientist in the Neuroscience Group at PTC, the Research Associate is involved in performing experiments using a variety of techniques, including analysis of RNA, protein, electrophysiology on brain tissue and imaging of cells and tissue sections. The successful candidate will: Work collaboratively with other PTC researchers to execute experiments in a highly matrixed environment. Analyze and interpret data generated. Assure that timelines are adhered to through efficient time management. Communicate effectively within the research team and across functional areas. Present data at internal meetings. etc.

Under general supervision, perform various manufacturing related activities for a GMP compliant Fill/Finish operation applying standard practices, techniques and procedures. Able to assist in the preparation of reports, records, etc., for assigned tasks. PRINCIPAL DUTIES: Familiar with related GMP procedures and requirements, as directly related to the position. Ensure that appropriate procedures and processes are utilized without unauthorized modifications. Ability to set-up, maintain and perform various manufacturing related activities as required for a GMP compliant Fill/Finish operation. etc.

We are seeking a talented and motivated R&D Associate / Specialist to join our highly dynamic neuroscience team. The successful candidate will be responsible for the design and execution of experiments to understand the mechanisms of neurodegenerative diseases, discover new therapeutic targets and validate novel therapeutic strategies. We are looking to recruit a candidate with in vitro experience and strong in vivo expertise in neuroscience and models of neurodegenerative disease. etc.

The Materials Tech 1 position at RTI represents an entry level function. Employees will develop technical skills in their assigned areas, an understanding of the rules and regulations that RTI administers, and the basic operating approach at RTI including: reading, understanding, and following work instructions; working in a team environment; and learning to work with minimal supervision. POSITION SUMMARY: Performs daily activities in accordance with applicable Standard Operating Procedures (SOPs) and Work Instructions (WIs). Unpacks, segregates, organizes, wraps, and packages various supplies and equipment. etc.

The Research Team leads target/enzyme-based projects for biotech and pharma clients to develop assays for high-throughput screening, and characterization of drug candidates and reaction mechanisms. The successful candidate will be organized and able to work under strict timelines in a fast paced environment. Primary responsibilities may include supporting the preparation of reagents and materials for running biochemical assays, assisting in executing biochemical assays utilizing state of the art MALDI TOF mass spectrometry, integrating automated liquid handling, and supporting fundamental laboratory functions.

The Clinical Trials Assistant (CTA) is responsible for providing support to the lead Clinical Trial Manager and the study execution team, clinical tracking and document maintenance as applicable to study vendors and clinical trial sites. The CTA will work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in compliance with GBT SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.

Develop, Implement and Install filter integrity testing methods to available automated Filter Integrity Testers (FITs) available on site to verify the integral of the vent filters that will used in the process for WFI Tanks, Autoclaves, supply clean compressed air and as required. Prepare protocols and reports for Validation Project Plan, Validation Master Plan, IQ, OQ, OQ, Traceability Matrix, Engineering test Plans, and Commissioning test strategies following the site Good Data and Documentation Practices (GDP) during protocol execution for qualifying the system or facility

Execute Validation and Qualification protocols which include installing, operating and maintaining of GMP Lab Equipment and Instruments (HPLC, UV-Vis Spectrometers, FTIR, GC, pH meters, Conductivity meters, Analyzers etc.) and manufacturing equipment like sterilizers and autoclaves to confirm if the instrument is compatible and compliant with Manufacturing, analysis, Company and FDA regulations. Perform validation and qualification documents include User requirement specifications, functional requirement specifications, Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validation summary reports, Change Control etc. for various lab instruments utilized by Quality control and Quality assurance teams;

Performing hands-on daily submission compilation and publishing activities associated with preparation of various dossier types and safety reports, for both new product marketing applications and/or marketed product maintenance packages. Performing overall quality of the assigned documents and dossiers which must comply with all internal Bayer best practices, meet global regulatory requirements, and facilitate the review and timely approval by appropriate regulatory authorities. Supporting the compilation of global dossiers and to deliver technically compliant submission documents/reports, which contribute to the development of submissions that meet the technical requirements and standards set by relevant health authorities.

Assists Upstream Manufacturing and Cell Culture Operations with Manufacturing in accordance with Master Batch Records and in compliance with GMP regulations and guidelines. Monitors Manufacturing Processes, Operates Analytical Laboratory Equipment and provides Operational Support for USP-MFG activities. Compiles electronic /laboratory notebooks, maintains laboratory equipment, and equipment logs and monitors supplies.

W.L. Gore & Associates Inc. is seeking an associate to join the R&D Technician Lab Team at one of the Fabrics Division’s facilities in Elkton, Maryland. The primary focus of this commitment is to support projects and hands on testing needs for our Durable Water Repellent coating on laminates. Performing lab functions accurately and efficiently, including but not be limited to: Hands on testing, sample preparation, and test method development. Writing and implementing procedures.Operating and maintaining analytical equipment

The Clinical Research Assistant coordinates the research and administrative activities of clinical trials for Gradalis. The Clinical Research Assistant works for the Clinical Operations Manager to provide support in compliance with the FDA Code of Federal Regulations (CFR), the ICH Good Clinical Practice (GCP) Guidelines, OHRP/DHHS guidelines and Gradalis Standard Operating Procedures.

As an Equipment Engineering Technician, you are responsible for supporting laboratory equipment management procedures, in alignment to our internal Quality Management System, to ensure better performance within Laboratory Operations. This will include global laboratory equipment support, sustainment, and operations activities across Production/Clinical, Product Development, Research and Development laboratories, in accordance with CLIA/CAP, FDA, cGMP and/or GLP guidelines.

Responsible for performing various routine manufacturing tasks following established procedures and cGMP regulations under guidance of a production supervisor and/or senior management. Follow production and manufacturing procedures. Perform equipment preparation, bulk drug formulation, and aseptic filling duties as needed. Train in various manufacturing tasks including, but not limited to: fill/finish, formulation, lyophilization, sanitization, component and equipment preparation, and finished product inspection and packaging activities.

Research Associate 2 is responsible for designing and performing experiments while collaborating and communicating effectively. Performs moderately complex experiments with input from supervisor. Able to summarize related groups of experiments. Provides input to the experimental design. Is able to analyze experimental data with minimal input from supervisor. Interprets experimental results in context of overall experimental goal.

You assist in determining the suitability of donors to undergo plasmapheresis prior to venipuncture. You establish rapport with donors to ensure overall customer happiness with the center to support long-term donation, all while ensuring donor confidentiality. Sets up, disconnects, and operates the automated plasmapheresis machines including response and evaluation of all autopheresis troubleshooting displays, documentation of exceptions, etc. Ensures the proper calibration and maintenance of autopheresis machines and associated equipment. May be trained to repair plasma equipment. Disconnects and disposes of all contaminated disposable equipment. Ensures proper cleaning of equipment and work area between donors. Maintains accurate and thorough documentation of production records.

Identify and screen donors by reviewing medical records and logs and evaluate the donor as to suitability. Screening includes asking health related questions and referring to medical staff when necessary; taking vital signs (blood pressure, pulse and temperature), performing fingerstick (HCT & Total Protein), and reviewing results using the applicable donor management system Maintain donor confidentiality at all times in all areas. Responsible for preparing donors for plasmapheresis procedure. Review donor record files for accuracy and completeness. Collect plasma by setting up the autopheresis instrument, performing the venipuncture and utilizing an Automated Plasmapharesis machine. Evaluate vein performance by checking data with known norms to identify possible problems; make corrections in order to expedite donation time and ensure product quality. Conducts all phlebotomies in compliance with all federal, state, and Biotest regulations.

You assist in determining the suitability of donors to undergo plasmapheresis prior to venipuncture. You establish rapport with donors to ensure overall customer happiness with the center to support long-term donation, all while ensuring donor confidentiality. Sets up, disconnects, and operates the automated plasmapheresis machines including response and evaluation of all autopheresis troubleshooting displays, documentation of exceptions, etc. Ensures the proper calibration and maintenance of autopheresis machines and associated equipment. May be trained to repair plasma equipment. Disconnects and disposes of all contaminated disposable equipment. Ensures proper cleaning of equipment and work area between donors. Maintains accurate and thorough documentation of production records.

The Clinical Trial Assistant (CTA) is primarily responsible for the coordination of activities associated with the setup and management of clinical studies under the direction of, or as delegated by a member of the Clinical Trial team. Responsibilities will range from clinical study coordination to data entry projects and general office work.

We are looking for a full-time Client Services Associate (CSA). The CSA is responsible for providing exceptional support to Guardant Health customers, the Guardant Health Clinical Laboratory, Sales Representatives, and our billing partners. CSA is responsible for receiving and responding to all types of communication: phone, email and web inquiries from customers (physician offices, laboratories, and hospitals), sales representatives and patients.

We have an immediate opening for an IT Support Technician to be based out of our corporate office in Buckhead, GA.  This is a full-time position and will be responsible for managing  HealPros's equipment in our facility or at the location of our technologists. Under the supervision of the IT Administrator, the IT Support Technician will perform troubleshooting techniques to resolve equipment issues and maintain it in good working order.

Performs repetitive assembly/fabrication/materials tasks using basic hand tools to build either parts for or actual temperature-controlled storage units, refrigerators/freezers and thawing systems, Cleans and packs units, handles material for distribution. Regular and reliable attendance, which includes punctuality and working scheduled overtime, is necessary to meet our commitment to provide quality products and service to our customer. Ensure that device history records are completed according to FDA GMP requirements. Complete nonconformance records according to established procedures and GMP requirements.

Performs repetitive assembly tasks using basic hand tools to build temperature controlled storage units, refrigerators/freezers and thawing systems or under counter temperature controlled storage units. May clean and pack units.

Assist in conduct of clinical studies. Provides licensed nursing coverage for studies and performs procedures as allowed by training and delegation. Assist in the conduct of clinical studies while providing licensed coverage. Performs all job responsibilities in accordance with standards of Good Clinical Practice (GCP), clinic standard operating procedures (SOP’s), and OSHA guidelines. Perform tasks such as EKG’s, vital signs, phlebotomy, insertion and maintenance of IV catheters.

Performs the set of tasks referred to as “window work” within the Chemstore while collecting, washing, and redistributing laboratory glassware. Escalates any washer issues discovered to the GMP department and communicates shortages/inventory needs to their Manager.

The primary duties of a Medical Equipment Service Representative involve client facing customer service and minor medical equipment repairs. Responsible for the pick-up and delivery of medical equipment, using a company provided vehicle to customer facilities. Periodically work on an on-call rotation that involves a 24/7/365 operation. Responsible for direct customer contact

The role of Analytical Development Research Associate is to aid in developing and refining analytical methods to characterize AAV vector products. The individual in this role will be a highly-skilled, talented and motivated researcher who will focus on the analysis of research/development-grade vector samples using multiple AAV-specific analytical methods. The candidate will participate in the comparison of AAV vector products produced internally with those produced externally as well as the optimization and qualification of molecular and bioanalytical assays such as HPLC and capillary electrophoresis.

The Process Engineer will ensure that the use of the best process engineering knowledge will be applied in scaling up chemical and spray drying projects to maximize customer satisfaction and Hovione’s interests and in compliance with all Federal, State, Local and internal policies. Plan and design manufacturing processes based on chemical procedures to run safely and effectively in a pilot plant/kilo lab in accordance with the best known practices ensuring cGMP compliance. Contributes to the Process Hazard Analysis (PHA) of all processes under his/her responsibility and assures that all identified hazards are addressed prior to performing any activities within operations.

This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. Our Configuration & QC Specialist plays a key role within ICON Laboratory Services (ILS). Support the Project Management Team (PM) in configuring and QC'ing new studies in all ILS systems according to the specifications of the Client Laboratory Worksheet (CLW) and create all supporting documents and site instructions to facilitate proper specimen collection, packaging and shipping, including visit requisitions, reference range tables and study specific Lab Manuals.

This unique opportunity is designed for individuals with a Bachelor's Degree in Life Sciences, strong organizational skills, excellent written and verbal communication, and working knowledge of computer systems including Microsoft Word, Excel, Outlook, and PowerPoint. ICON, a leading Clinical Research Organization, is seeking passionate, resilient and inspiring Graduates to join our team as a Clinical Trial Assistant. This opportunity offers an entry-level permanent position to highly skilled individuals interested in a career in clinical research.

Our Configuration & QC Specialist plays a key role within ICON Laboratory Services (ILS). Support the Project Management Team (PM) in configuring and QC'ing new studies in all ILS systems according to the specifications of the Client Laboratory Worksheet (CLW) and create all supporting documents and site instructions to facilitate proper specimen collection, packaging and shipping, including visit requisitions, reference range tables and study specific Lab Manuals.

Secondary operations and simple machining, including manual machining, grinding, honing, deburring, squaring of stock, and precision material removal to complex specifications with minimal instructions to the requirements of supplied Engineering Documentation. Maintenance of tool room equipment, and of production line molding, extrusion, and assembly equipment are vital functions of the role. Purchasing and stocking of hand tools, metalworking tools, and machining tools. Organization, cleaning, and maintenance of a 5S systematic program for workplace organization in the tool room.

Develop a high level of familiarity and knowledge of the study protocol and flow chart of study procedures. Develop a strategy for implementing study procedures in compliance with study protocols. Performs laboratory procedures (g., preparation for admission testing, safety labs, and processing of biological specimen samples, shipment of samples and documentation of sample processing steps, etc.) as required by study protocol under the supervision of the Clinical Research Coordinator, Principal Investigator, and Sub-Investigators.

Deployment and relocation of desktop systems. Maintenance and repair of desktops, printers and associated peripherals. Supports other IT staff in installing, configuring, testing, maintaining and troubleshooting network, systems hardware and software. Administration of FDBT’s Building Information Management System (BIMS).

The Downstream Manufacturing Technician I will work directly with viral purification (either whole particle or split particle), continuous flow centrifuge operation, and sucrose gradient separation, techniques for filtration and chromatographic separation (i.e. column chromatography and HPLC) and viral inactivation.

Perform calibrations of complex instrumentation on production, laboratory and facility systems ensuring all systems and devices are calibrated in accordance with manufacturer’s specifications and FBDT SOP’s. Assist in the development of investigations resulting from ‘out of tolerance’ conditions with respect to instrumentation. Assist in interfacing with calibration contractors ensuring work is compliant with FBDT SOP’s and cGMP’s to maintain state of the art technology within the facility. Assist in maintaining all calibration records, work orders, and investigations in an orderly and accurate manner in compliance with cGMP’s by the utilization of the site CMMS and Document Management Systems.

Assist in the development, optimization, and scale-up of chromatography processes (including affinity, IEX, HIC, etc.) and filtration processes (including UF/DF, depth filtration, and sterile filtration, etc.). Operation of chromatographic systems (GE AKTA, and other Unicorn based equipment). Maintaining detailed laboratory notebooks following FDBT procedures. Participate in developing and carrying out experimental protocols.

Operate a number of machines used in the manufacturing of pharmaceutical products and have a good working knowledge of elements used in association with batch production, such as equipment cleaning, running filling machines, etc. The operator is responsible for producing acceptable product that meets G&W internal standards, and is also in conformance with GMP and safety standards. 3rd Shift Hours are 11:00 p.m. to 7:00 a.m.

The Laboratory Technician performs an entry level role in the testing of clinical DNA specimens for the purpose of diagnosing genetic disease, using manual and automated methods in a team environment, and following established policies and procedures in a professional manner.

A GeneDx NGS Lab Technician performs a higher than entry level role in the testing of clinical DNA specimens for the purpose of diagnosing genetic disease using manual and automated methods in a team environment, and following established policies and procedures in a professional manner.

Generation Bio seeks a highly motivated Research Associate to support analytical molecular biology activities in a cross-platform function. The successful candidate will work part of an analytics team responsible for the development and testing of research drug substance, as well as performing experiments to better characterize and understand the composition of our drug. Perform bioanalytical assays, including purity, copy number, expression, and activity assays to support the Production, Pre-clinical, and Process Development groups

Our Lab Techs strictly adhere to laboratory SOPs to ensure quality and safety and often communicate with our customers via email. They prepare DNA templates which include preparation, amplification and PCR purification and load these samples onto the sequencers. They also work to prepare buffers and other related solutions.

Our Lab Techs strictly adhere to laboratory SOPs to ensure quality and safety and often communicate with our customers via email. They prepare DNA templates which include preparation, amplification and PCR purification and load these samples onto the sequencers. They also work to prepare buffers and other related solutions.

Work collaboratively with bench scientists, comprehend project objectives, evaluate and provide informatics solutions. Develop and implement bioinformatics analyses, applications, and workflows. Integrate statistical analysis to project design and data interpretations. Work closely with IT specialists to build robust infrastructure.

Conducts general molecular biology tasks, including nucleic acid purification, quantification, amplification and analysis on multiple platforms. Prepares reagents and solutions as needed, using appropriate procedural and documentation methods, including industry standard good laboratory practices. Identifies and solves problems in experiments or protocol designs, suggests improvements. Prepares documents meeting company standards, including data summaries, reports, SOPs and procedures

The Research Associate II will execute a range of molecular biology and bioanalytical procedures, reagent preparation, and laboratory duties under supervision for our technology development team. Conducts general molecular biology tasks, including nucleic acid purification, quantification, amplification and analysis on multiple platforms. Prepares reagents and solutions as needed, using appropriate procedural and documentation methods, including industry standard good laboratory practices

This position delivers high-quality fermentation data by applying optimal fermentor operating procedures, communicating observations clearly to Fermentation Science personnel, and works collaboratively to maximize experimental precision. This position will interface closely with the Fermentation engineers and scientists in the Fermentation Science Group to produce conclusive fermentation results that will guide process optimization and scale-up efforts

As a Clinical Laboratory Technologist I or II or III you will work under general supervision and you will be responsible for accurately performing highly complex laboratory testing procedures. You will determine acceptability of specimens for testing, prepare clinical specimens and identify specimen related problems. You will also analyze specimens, review and release test results. You will have the means to prepare stock solutions, reagents and cocktails used in the laboratory. You will then test these based on standard criteria and document all observations.

As an Order Entry Specialist I, you will enter patient demographic characteristics and insurance information into a proprietary database using company specific software and internal documents. Additionally, you will input diagnosis codes, charges and verify insurance in accordance with company policies.

As a Laboratory Assistant you will assist the department technologist in performing various basic laboratory procedures laboratory instrumentation to facilitate production. This in an entry level position in the clinical laboratory job category and employees in this position may not manipulate samples.

We are looking for a Laboratory technician to assist our daily production tasks. The successful candidate should have biology or related science background, excellent time management skills, strong problem solving ability. He or she will need to work directly with production team, fit with collaborative and competitive culture in GenScript.

GigaGen seeks a talented, highly motivated Research Assistant to work alongside PhD-level scientists on research funded by a $50 million co-development deal with Grifols, plus Phase II SBIR grants from the NCI and NIAID. This project involves high-throughput discovery and development of therapeutic antibody drug candidates from human and mouse immune repertoires. The work involves significant cell culture work, including a bioreactor and flow cytometry.

We are looking for someone who is excited about the field of synthetic biology and loves a challenge. We want a person who is eager to learn and has a desire to utilize automation to work more efficiently. Our ideal candidate will elevate our team through creative solutions while working closely with other foundry groups. Responsibilities include: Enzyme purification and characterization, Data analysis, Automation of protocols

Lead/manage assigned sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study. Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance. Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits

Over three years, our Future Leaders Graduate Program will challenge and support you to grow professionally and personally. You’ll have three stretching rotations within Pharmaceutical or Consumer Healthcare Supply, depending on your area. In both cases, you’ll take on business-critical roles that offer amazing insights into our end-to-end supply chain. You’ll learn about the synergies and challenges that come with delivering optimum value to the business and the customer.

Over three years, our Future Leaders Graduate Program will challenge and support you to grow professionally and personally. You’ll have three stretching rotations in business-critical roles within consumer healthcare supply. Your responsibilities will depend on your engineering discipline, but whatever your specialist area, you’ll get to meet senior leaders and network with other graduates. You’ll also improve your technical skills while gaining valuable leadership expertise.

As a Packaging Operator you will manually assemble, glue, tape and package boxes, cases and other material as needed.  Activities also involve set-up, operation, and verification of printing, weighing and robotic equipment as well as staging packaging material, documenting, cleaning, and performing in-process quality checks.   The work involves lifting up to 50 lb. containers on a regular basis and moving pallets, totes, and film using a hand truck or similar tools.  A thorough understanding of each job function within the work center is essential. 

Responsible for strategic and operational activities of clinical research studies in blood cancer metabolism to ensure adherence to intended timelines and achievements of study goals, while ensuring quality by FDA, EMEA, ICH and GCP guidelines. Providing oversight in clinical research Organization (CRO), Central labs and other external vendors to ensure deliverables are met and methods of communication are developed to facilitate an efficient workflow. Facilitating interdisciplinary activities, participating in the clinical trial working group (CTWG), Site Management Team (SMT), and internal team meetings to meet the goals and established timelines

The Mechanical Engineer, Research & Development will support the Critical Care Mechanical team working on new product designs, technology development and sustaining of core product lines with an emphasis on hands on new product development.

A technical, lab-based position is available within Pfizer’s Cell Line Development (CLD) organization. The position will be primarily involved in mammalian CLD portfolio advancement, novel technology development and process optimization. Working with a group of scientists, the successful candidate will be responsible to perform platform cell line development activities to fulfill the need of moving Pfizer’s biotherapeutics pipeline projects towards either clinical or commercial developmental phase. This role will involve all aspects of cell line development from vector design/construction, cell culture maintenance, clone screening, and cell line characterization. etc.

This position is an analyst role in the QC Bioanalytical laboratory. Experience with ELISA, PCR, and/or slot blot is preferred. Analyst will be responsible for ensuring the routine testing is scheduled and completed within appropriate timeframes as needed for manufacturing to maintain schedules (STAT testing) or the QA disposition group to disposition batches. Other responsibilities may include, SOP revisions, validation/qualification testing support, etc. etc.

The Chemist I position, reporting to the Director, Analytical Development, will operate under moderate supervision to perform chemical analyses of samples according to standardized procedures to determine the identity, content, purity, stability, and other characteristics of the samples analyzed. He/she may perform method development activities related to the development of methods for testing of raw materials and clinical drug product as well as formulation development. etc.

Under the general supervision of the Director of BME, the Research Specialist I, II or III will support R&D in conducting research projects by contributing to the following: develop protocols for and maintain laboratory equipment; troubleshoot and resolve problems; ensure compliance with lab protocols and safety standards, policies and procedures; performing complex data gathering and analysis. This role serves to assist with conducting pre-clinical research aimed at validating, testing products and discovering, developing innovative medical technologies. etc.

The Research Associate will play a key role in advancing exploratory gene therapy programs that leverage our cutting-edge piggyBac® DNA Modification technology. Responsibilities: Actively participate in our proprietary gene therapy platform technologies to create new human therapeutic candidates. Develop and perform research involving various in vitro and animal laboratory techniques including ELISA, cell/tissue isolations, microscopy, in vivo procedures and animal imaging. Understand and analyze results, and communicate findings in team meetings. Maintain laboratory equipment and facilities, as required.

As an Associate Scientist, you will use state-of-the-art technologies to perform high-quality sample testing for key pharmaceutical clients across the industry. Your sample preparation and sample analysis skills are an integral piece in helping PPD accomplish our goal of helping bring life-changing therapies to market. Responsibilities: Problem solving with assistance pertaining to extraction and/or instrumentation problems. Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines. etc.

As an Associate Scientist/Scientist, you will work onsite at the client lab facility using state-of-the-art technologies involving preparation and dose analysis of formulations to support toxicology, pharmacokinetic, and other in-vivo studies. You will be responsible for laboratory equipment calibrations and verifications, ordering supplies, as well as designing and conducting Pre-formulation characterization of small molecules. etc.

As an Assistant Scientist, you will use state-of-the-art technologies to perform high-quality sample testing for key pharmaceutical clients across the industry. Your sample preparation and sample analysis serves as an integral piece in helping PPD accomplish our goal of helping bring life-changing therapies to market. Responsibilities: Performs a variety of routine sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing. etc.

As an Assistant Scientist, you will use state-of-the-art technologies to perform high-quality sample testing for key pharmaceutical clients across the industry. Your sample preparation and sample analysis serves as an integral piece in helping PPD accomplish our goal of helping bring life-changing therapies to market. Responsibilities: Performs a variety of routine sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or biological matrices for stability and analytical testing. etc.

The Associate Process Engineer, Upstream will work within the Process Development team and will participate in the development of upstream cell culture, delivering best-in-class process design for viral vector drug substances and drug products, for the development of in vivo and ex vivo gene therapies. The candidate will support the process development, process characterization and tech transfer of said processes for GMP manufacturing. The candidate will assist in the clinical progression of in vivo and ex vivo gene therapies by designing and executing process development experiments across a variety of process scales. etc.

Accomplishes targeted sales and increases the market share of key (bio) pharmaceutical products. Calls on a select number of high value physicians in a specified geographic area and focuses on establishing durable relationships, effectively delivering product information, and aiding in training. Helps customers develop reliable processes for reimbursement and access. Is comfortable providing information to the entire office staff and has the ability to identify new sales opportunities and leads in their territory.

To collect, document, and manage pertinent data including animal observations, test material administration, and clinical sample collection in compliance with appropriate SOPs and regulatory agency guidelines. To monitor animal health and welfare in compliance with the Animal Welfare Act and help maintain facilities for AAALAC compliance. Assess and document clinical observations, body weight data, food consumption data, environmental data, and other data on the appropriate data collection system (or by hand when necessary).

Machine Operator to operate equipment to produce high quality diet in accordance with Envigo Teklad standards. Operate automated manufacturing process in accordance with established standard operating procedures. Follow production instructions of immediate supervisor to insure a safe work environment. To ensure a safe work environment; wear all PPE and all established safety procedures without exception.

To care for laboratory animals, their environment, and maintain records of their productivity and growth. To learn how and to maintain animals in inventory, to prepare animals for shipment, and to medicate or inject animals. Provide food, water, and clean housing to animals according to a rigid schedule. Maintain detailed records of animal production and inventory in precisely weighed and aged groups.

Process incoming shipments from suppliers, ensuring accuracy of all product data. Aliquot product into vials and assemble kits for customer orders and global stocking. Work with colleagues across the business to resolve discrepancies quickly. Maintain accurate inventory levels using both manual and automated systems. Fulfill customer orders using internal systems and processes, ensuring accuracy of all products in all orders. Work with teammates to improve the efficiency and accuracy of any processes implemented within the Logistics Department using creativity and resourcefulness.

Perform assays on vaccine products, process intermediates, and related experimental samples using SDS-Page, Capillary Electrophoresis, ELISA, Biacor, nucleic acid quantification and other biochemical/analytical tests(e.g., spectrophotometric, electrophoretic, immunochemical methods). Maintain records and test results following good manufacturing practices (GMP).

he Associate Scientist position is an intermediate-level professional position involved in somewhat complex day-to-day activities in a laboratory setting under prescribed processes (protocols, standard operating procedures, methods, etc.). Responsibilities include completing work for research and development under CGMP and/or GLP guidelines for studies, documentation, etc. Assisting in conducting, monitoring and reporting studies to ensure data accuracy and report quality. Providing somewhat complex analytical work on projects and studies using a range of analytical techniques and instruments.

Assist the Study Director with all phases of study design, scheduling and conduct. Act proactively to identify problems and potential problems. Assist in writing, reviewing and editing reports, protocols and SOP’s. Set-up and conduct experiments in accordance with Protocol and SOP's. Efficiently carry out procedures necessary to complete each project with minimal supervision. Meticulously maintain precise records of all experiments in accordance with good laboratory practices.

Fill pails, drums, and totes with raw materials, intermediates, and finished products (including forklift operation). Run reactors/product blends per operating directions. Clean transfer lines within the plant and to the drumming station. Unload empty packages and stage for use, load box trailers with product for transfer. Maintain good housekeeping, perform housekeeping audits, run karl fisher analysis on titrators, and assist in filter change-outs, perform fork-lift inspections, etc.

Apply process engineering knowledge and skills to support the synthesis of starting materials pharmaceutical intermediates and final bulk products in a safe, efficient and environmentally responsible manner. Specifically, the process engineer is responsible for demonstrating process understanding, monitoring, and managing process performance.

This role assists with financial operations and reporting in Global Strategic Outsourcing Department. Responsibilities include supporting the Associate Director with contract administration, budget estimates, payment processing and reporting to facilitate the outsourcing strategies and activities of the Research & Development Organization. This role also requires the ability to obtain appropriate information to administer contracts and payments for outsourced agreements and communicates regularly to internal and external stakeholders on status of contracts and payment requests.

This position’s responsibilities include QC testing in the Reagent and Consumables Manufacturing department at ProteinSimple. The primary responsibility will be working with QC and Production teams to schedule and test Maurice and Simple Western consumables in a timely manner.Precise and meticulous observation and recording of all details of the assay, which are not limited to but including: lot numbers, and physical observations of materials

The responsibilities of this position are to assist with feasibility, product development, verification, and technical support of immunoassays. Optimize components and performance, develop manufacturing procedures, transfer product/process to production, and perform necessary troubleshooting. Work on problems of moderate scope where analysis of situation or data requires a review of identifiable factors. Perform additional duties as assigned.

The Quality Engineer plans and directs activities concerned with development, application, and maintenance of quality processes, materials, and products. Additionally, responsible for investigation manufacturing and customer nonconformance’s, determining root causes and corrective actions, reviewing and approving protocols and final reports and developing product specifications and sampling plans.

To perform laboratory QC Microbiological testing for in-process and finished product, water sampling testing, and routine and batch processing environmental monitoring in aseptic classified cleanrooms. Perform Bioburden, Endotoxin, Total Plate Count, Coliform, Bacteriostasis &Fungistasis (B&F) and Biological Indicator testing. Perform clean utilities (compressed air, Nitrogen, WFI/DIW and Clean Steam) sampling and testing. Initiate and investigate microbiology related deviations (NCEs/NOE), OOS investigations, and implementing appropriate CAPAs as needed.

The GMP Support Technicianwill perform a variety of tasks in support of the daily production of sterile cell therapy product. Operations are predominately performed within a cleanroom environment under Current Good Manufacturing Practices (CGMP) conditions. Provides operational support for manufacturing activities including media/reagent preparation, kitting, cell freezing and equipment/materials staging. Follow batch records, SOP’s and other cGMP documentation; complete all documentation in a clear and concise fashion

Assist with troubleshooting, root cause analysis and identification of corrective actions to support Pharmaceutical Development or GMP Manufacturing equipment and process issues. Support efforts to scale-up & undergo technical transfer of production processes to GMP Manufacturing. Lead planning, execution, and documentation of studies related to design of novel drug products. Work cross-functionally across Quality, Research, Clinical, and Manufacturing teams to achieve company goals.

The Biology Team at FORMA Therapeutics seeks a Research Associate/Senior Research Associate with a strong background in cancer biology to contribute to FORMA’s pre-clinical and clinical projects. The ideal candidate will be a highly motivated individual with a strong technical background in cancer biology. Develop, optimize and perform assays using molecular biology procedures and technologies including qPCR, quantitative western blots, ELISA. In vitro culture of cancer cell lines and primary cells as well as blood/tissue is required.

We are currently looking to add to our Clinical Lab staff at various levels and shifts. Perform highly complex testing according to established SOPs (NGS library prep, hybridization, and sequencing). Operate automated 8-span and 96-head liquid handling platforms for sample processing. Complete projects fitting of level of expertise and is able to deliver results with minimum guidance.

The Client Services Representative is a vital position at FMI tasked with the responsibility of responding to and resolving a wide range of client inquiries and requests as well as acting as a liaison between departments within FMI, and between FMI and its partners, customers and the patient. The incumbent operates in a supportive function within the fast-paced Client Services department.

The Chemist, Method Development has broad expertise in routine as well as complex chemical methods of analysis. The incumbent conducts all aspects of Quality Control testing including method development, method validation, experimentation, routine and non-routine quality control testing, and record keeping. The incumbent must be able to develop, validate, and implement methods that meet project needs. The incumbent is typically assigned the more complex test methods due to their advanced training in specialized methods of analysis. The position is responsible for conducting studies with increasing complexity in nature and solving problems to ensure a robust method can be performed in the laboratory.

Responsible for providing technical support to operations in terms of equipment/system/process initial validation and equipment/system/process requalifications. Will participate in process and equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. The individual must become certified to enter Controlled Areas of the plant (class 100, 10,000 and 100,000). The ability to write reports clearly, concisely and accurately; accurately record data and a basic understanding of statistical analysis is also required to perform these duties. Weekends and Off-shift hours are periodically required.

Responsible for the operation and performance of high speed pharmaceutical equipment in a clean room (class 100) environment. Aseptic Control Operators are responsible for the cleaning, changeover, setup, startup, operation, and breakdown of filling lines. Additionally, they may be assigned tasks related to the general upkeep of the clean rooms, such as unloading ovens and sterilizers, performing routine cleaning, and performing minor maintenance. All of these activities are governed by strict procedures and regulations and require a high degree of training. Therefore, Aseptic Control Operators must complete all required training, and follow all applicable Standard Operating Procedures, Batch Records, and Protocols, and must be familiar with current Good Manufacturing Practices.

This candidate will perform routine lab experiments involving optics in a corporate research lab. The research project testing is completed as part of a process group in high throughput laboratory. RESPONSIBILITIES: Operate and maintain a variety of laser and optical testing instruments. Work with optical alignment on optical bench using light sources (white light, lasers, LEDs) and imaging systems (cameras, photodiodes). Sample collection, preparation, routine analysis, and interpretation results. etc.

Seeking an analytical chemist to perform QC analysis of inhalation device components. RESPONSIBILITIES: Sample preparation and analysis using GC-MS and GC-FID. Testing methods using LC is also possible. Perform analysis on inhalation device components - performing extractable and QC testing on plastic, metal, and rubber components. Perform appropriate documentation of work in a GMP environment utilizing Electronic Lab Notebook (ELN), LIMS, and other software. etc.

We are currently recruiting for QC Associate, reporting to Manager of Quality Control. This position will be based in South San Francisco.

The Chemist II, under general supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation. Detects, participates and reports on OOS/OOT/NOE and other investigations. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. May train less senior staff. etc.

Quality Associate I or II (QA Floor Support) is responsible to provide Quality Assurance support real-time for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA on the Floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed. etc.

Entry manufacturing engineering role in a dynamic and fast growing manufacturing company. Working with advanced products and processes in the revolutionary life sciences and medical instrumentation industry. Providing technical support to our manufacturing operations to overcome challenges and implement solutions.

The Assay Services Scientist I / II works primarily with cell culture-based bioassays, executing antiviral bioassays, ELISAs and other highly sensitive immunoassays for characterizing proteins and reagents; analyzing data and drafting client reports; and developing new and custom assays to support the growth of the Assay Services Group. ESSENTIAL DUTIES AND RESPONSIBILITIES: Execute immunoassays on ELISA, and other highly sensitive platforms like Electrochemiluminescence (MSD), Single Molecule Array (Simoa), and Single Molecule Counting (Erenna). Execute antiviral and antiproliferative cell-based bioassays. etc.

To ensure the quality of PBL reagents the Quality Control (QC) Scientist I will perform release and stability testing of interferons, antibodies, and manufactured ELISA kits. In addition, the QC Scientist I will perform bioassays or immunoassays to troubleshoot relevant customer issues and design and initiate experiments and projects to improve the quality of PBL products. The QC Scientist I may also serve as back up to the Product Development, Assay Services, or Manufacturing departments as needed: such additional duties may include designing and performing ELISA testing protocols, custom bioassays, and solution preparation. etc.

As a Quality Engineer at Penumbra, you will participate in all aspects of product manufacturing in order to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. You will apply your passion for detailed analysis to identifying problems and determining the appropriate course of action. You will be looked to for ensuring compliance and building a culture of quality within your project teams. etc.

Performance Validation is seeking full-time Level 1 Validation Engineer/Specialists in the following locations: Indiana, Michigan, Illinois, and Kansas. The Level 1 Validation Engineer/Specialist is an entry level position and reports directly to the Division Director or Manager and is assigned to one or more project teams to perform work for Performance Validation’s customers. etc.

Located in Menlo Park, CA, we are seeking a talented and highly motivated Research Associate to join our Operations Team. You will participate in the daily activities of the laboratory in order to effectively maximize turnaround time, equipment, and material utilization within budgetary constraints while adhering to quality technical standards. This is a 3 months temp to hire position. We have Multiple openings for swing and day shifts that include one weekend day (Tues - Sat or Sun - Thurs). etc.

NGM Biopharmaceuticals, Inc. is seeking a highly motivated Research Associate to join our Nonclinical Safety development group. This will be a temp to full time position.

We are currently offering a unique opportunity for a highly motivated researcher to join our team with experience in immune, in vitro, cellular and cancer biology. JOB DUTIES AND RESPONSIBILITIES: Execute a broad range of cell based functional and phenotypic assays for characterization of engineered NK and T-cells to accelerate projects in pre-clinical development. Conduct in vitro mechanism of action studies using primary human or mouse immune cells and cell lines to evaluate activity of candidate therapies. etc.

We are currently offering a unique opportunity for a highly motivated development associate to join our team with development experience in cell therapy. JOB DUTIES AND RESPONSIBILITIES: Support process development of phase appropriate cell therapy production processes. Evaluate raw materials and culture systems for use in cell therapy manufacturing processes. Support process optimization efforts to increase process robustness, reduce costs and improve yield. etc.

The QC Associate is a key position within the organization with significant prospects for career growth as the company continues to increase the breadth and scope of its business. This position reports directly to Sr. Vice President and a Consulting Quality Assurance Unit. Responsibilities include butarenot limited to: Become and maintain intimatefamiliaritywith all applicable FDA and EPA GLPand other appropriate regulations and guidelinesas well as with the company SOPs and other QA systems. Supervise day to day quality control operations and documentation. etc.

The Quality Control Chemist I: Performs routine testing to assess the conformance of raw materials, finished products, and/or stability samples to predetermined product specifications. Performs routine testing in conformance with approved procedures, accurately and concisely documents data, and reports results. Demonstrates a basic knowledge of SOP’s and GMP regulations as related to the pharmaceutical quality control laboratory. etc.The Quality Control Chemist I: Performs routine testing to assess the conformance of raw materials, finished products, and/or stability samples to predetermined product specifications. Performs routine testing in conformance with approved procedures, accurately and concisely documents data, and reports results. Demonstrates a basic knowledge of SOP’s and GMP regulations as related to the pharmaceutical quality control laboratory. etc.

We're looking for a detail oriented QC Analyst I. The ideal candidate will be proficient in method validation and equipment qualification with minimal supervision, as well as performing chemical testing for raw material, water and in-process samples supporting the manufacturing process. Demonstrates self-starter and independent worker with strong commitment in quality and compliance. Excellent analytical and wet chemical techniques. Strong team player with the ability to communicate effectively both verbally and in writing. The person will join our Analytical team to support routine testing such as SDS-PAGE, FTIR, HPLC/UHPLC, ELISA, UV-VIS and others. etc.

We are seeking a Research Associate with experience in cell biology and immunology to join our Nurix drug discovery team. Nurix is devoted to unlocking the therapeutic potential of the ubiquitin system to explore the possibility of modulating targets previously believed to be “undruggable”. Ubiquitin ligases play numerous roles in immune cell function, autoimmunity, inflammation and anti-tumor immunity. The successful candidate will support early drug discovery efforts in inflammation, oncology and immuno-oncology (IO). etc.

The QC Analyst I/II performs quality activities in support of product production and releases. The position has interaction with other internal departments, including Quality Assurance, Validation, Calibration, Materials, and Logistics. The position also has interactions with external entities including contractors and suppliers. The QC Analyst I/II performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, and reporting results. etc.

The qualified candidate will support company’smolecular biology operations,principally performing DNA cloning and molecular biology experiments following protocols. Job Requirements: Perform experimentsfollowing protocols for plasmid DNA purification, DNA digestion, gel electrophoresis,DNA fragment purification, ligation, transformation, DNA quantitation, DNA sequencing, PCRand cell culture. Responsible for assigned lab duties, maintaining lab stocks, solutions, reagents, and supplies. etc.

As a member of the Miltenyi Biotec Manufacturing team, you will have the exciting opportunity to participate in both the manufacture and process development of T-cells and multiple other cell therapy products within a GMP environment. The unique duties of this position will primarily consist of manufacturing primary human cells including activities that involve graft engineering for cellular therapies as well as supporting the development of scalable cell culture processes. etc.

The Animal Technician provides primary care to the animals in the large animal toxicology department and performs routine invasive and non-invasive technical procedures on studies allocated to the team while ensuring that procedures are conducted according to protocol, SOP requirements, Good Laboratory Practice (GLP) and United States Department of Agriculture (USDA) regulations and the guidelines.

Perform peptide related lab operation under close supervision. Assist in setting up and operating peptide related lab equipment. Perform HPLC, mass spectrometry, and other analytical techniques. Follow standard operating procedures (SOP) to perform various laboratory tasks. Complete training and development on an ongoing basis

This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.

Provides calibration and instrumentation support for processes, operations, and buildings on site. Responsible to execute scheduled calibrations, preventive maintenance and corrective maintenance on instrumentation and control devices in compliance with facility procedures and work instructions. Works within clearly defined standard operating procedures and/or scientific methods and adheres to quality guidelines

Responsible for preparing the donor, donor area and equipment for the pheresis process. Monitors the donor and the pheresis process, responds to specific alarms or signals that may occur during the process. Maintains alertness and awareness to any reaction donor may have during or after the pheresis process and notifies appropriate staff.Uses Personal Digital Assistant (PDA) to record incidents that occur during the pheresis process, such as machine alerts and alarms, volume variances and donor adverse events.

The Clinical Safety Scientist I is responsible for managing serious adverse events (SAEs) in clinical trials or post-marketing programs, focusing on all aspects of the collection, processing, evaluating and reporting of cases in accordance with CTI’s Global Drug Safety and Pharmacovigilance processes, International Council for Harmonisation (ICH) guidelines, Good Clinical Practices (GCP), applicable regulatory guidelines and study procedures. This individual will track cases from receipt to closure, perform verification of safety data, and will utilize clinical / pharmacovigilance judgment in coding of serious events and synthesizing complex clinical information into accurate and complete narratives.

To increase product awareness through telemarketing and account support with pharmacies to help achieve company sales targets and improve profitability. To provide communication to key stakeholders for the field sales team to generate new business and maintain current business. Interact with pharmacies by use of appropriate questioning, clarification and language to build effective relationships to increase sales. To speak positively and enthusiastically about the company and its products to ensure that a professional company and brand image is provided at all times.

This will be an entry level position that will provide a tremendous learning opportunity for the ideal candidate. The candidate will get to learn in-depth the functioning and nuances of a Sample Management group and also gain experience with the numerous assays that assess and characterize the properties of the compounds. The position demands an individual who is a quick learner and has a proactive attitude to pitch in to support research activities and help with dispensing compounds, trouble-shooting instrumentation, and running assays.

This position is accountable for the execution of procedures for purification manufacturing and support area of manufacturing using SOP’s and batch records. Operating production equipment for purification that may include process monitoring, purification and formulation. Interface with Quality Control department to submit in-process samples and coordinate environmental monitoring during key process steps. Demonstrate understanding in scientific concepts, technical operations, safety, and Good Manufacturing Practice.

This position is accountable for producing and delivering large and small-scale media and buffers to support Upstream and Downstream Manufacturing Operations. Batching and delivering both large and small-scale media and buffer batches. Assisting in the review & creation of operation documents by providing input to technical composition of documents. Following accurate oral & written procedures in operating production equipment & performing processing steps

Develops new or modified process formulations, defines processing or handling equipment requirements and specifications, and reviews processing techniques and methods applied in the manufacture, fabrication, and evaluation of products. Involvement may begin at any step from pilot plant to full-scale manufacturing. Coordinates design requirement review with appropriate engineering/scientific personnel to ensure compatibility of processing methods. Compiles and evaluates test data to determine appropriate limits and variables for process or material specifications. May conceive and plan projects involving definition and selection of new concepts, equipment automation technology, and approaches in the processing or development of new or improved processes.

The Rep !, Client Services Representative is a critical position in providing customer service satisfaction and representing DNA Diagnostics Center (DDC). Answer inbound telephone and email contacts. Able to explain and promote DDC's products and services professionally. Quickly understand and analyze customer needs, listen actively

The Business Development Manager is responsible for identifying new clients and for establishing and maintaining sales relationships. This candidate is also responsible for maintaining and strengthening relationships with existing clients. As a successful candidate, you will need to meet the following technical requirements and qualifications: Place outbound calls to market to qualify and build relationships with contacts, and secure meetings. Educate prospects on the eCaseLink suite of products and services.

Develop test plan, test cases, test scenarios based on Users Stories and product’s design description to meet business requirements and technical specifications. Estimate, plan, and coordinate testing activities. Perform ad hoc, functional, integration, and regression testing. Identify software defects and submit problem reports via bug-tracking system

In this role you will contribute to the development of cell-based assays and ex vivo methods to evaluate gene editing. An ideal candidate should have a background in cell culture, ex vivo tissue dissection methods, and a strong interest in genome editing. Perform ex vivo tissue dissection and cell isolation. Perform routine DNA/RNA extraction and PCR, western blot, and ELISA. Development and optimization of cell-based assays

The Biologist-QC will provide technical support including consultation/recommendation on various analytical topics to management where appropriate.  He or she will support and sometimes manage laboratory related projects affecting QC.  The Biologist will assist other laboratory personnel in the implementation of new technologies into the QC lab and improvement of existing processes.  The Biologist will also coordinate non-routine analytic work and sample analysis to support relevant projects and initiatives when needed. The position will also include routine testing of in process and final product samples for the release of veterinary vaccines.

Develop, implement, and continuously improve process automation solutions within IDAP to ensure that business goals are achieved. Ensure that process automation solutions/systems are in-control, capable, and compliant. Stay tightly aligned and actively involved with internal customers. Understand their issues, priorities and objectives. Respond to and implement customer requests. Troubleshoot problems. Assure that all capital projects are aligned with the Automation Strategy and that all established standards are followed.

Partner with health care professionals and those involved with patient care as a product expert to tailor solutions for patient therapy. Sell in a changing health care environment, utilizing critical thinking and a strategic mindset to understand the environment (payer, health systems, business) and gain access to the customers to make an impact on patients’ lives. Work in your own territory and also partner with team members and alliance partners for success in the territory

This position is responsible for the inspection and packaging of product. Will perform all aspects of Inspection and Packaging with the ability to assist in day to day operations. Execute and document procedural steps in compliance with cGMP standards. Perform room clearances in accordance with relevant Standard Operating Procedures. Perform 100% visual inspection of product and classify rejected materials utilizing approved categories within required timelines (Qualification)

Part time. Receives and directs calls, visitors, vendors, service personnel, and all paperwork in a confidential manner. Provides clerical and administrative assistance to leadership and teams. Maintains effective working relationships with co-workers, vendors and clients. Schedules appointments and travel arrangements, as requested. etc.

Principal Duties and Responsibilities. Independently conduct testing according to written instructions. May be requested to conduct more involved studies. May perform USP and EP monograph testing activities using wet chemical and analytical instrumentation. May conduct routine testing per NAMSA SOPs as well feasibility, protocol driven methodology, and/or method verifications on at least one of the following instrument types: HPLC, GC, or ICP, etc. Works with management to ensure large studies are completed on or before the due date. Prepare and maintain the reagents required for testing. etc.

The Manufacturing Research Associate I/II, CodeSet Manufacturing is responsible for supporting the production of reagents used in nCounter Analysis Systems. The role requires learning and performing both manual and automated production processes for the manufacture of raw, intermediate and final reagents needed for the multiplexed detection and quantification of many different types of target molecules from biological samples. This individual learns to use professional concepts and apply company policies and procedures to resolve routine issues, in addition to acquiring the skills to operate equipment, perform SOPs, navigate Document Control systems, ERP systems, etc. etc.

Natera is currently seeking a Clinical Data Operator to join the operations team. This position accessions patient samples according to standard operating procedures (SOP) with high efficiency and accuracy. PRIMARY RESPONSIBILITIES: Create new orders on Laboratory Inventory Management System (LIMS) and perform necessary checks to ensure proper accessioning. Accession samples with high accuracy and efficiency. Accurately enter patient data into the Laboratory Inventory Management System (LIMS). Ensure that the information in LIMS is up-to-date. Scan test requisition forms and attached paperwork. Ensure that all paperwork belong to patient and upload to case. etc.

Natera is currently seeking a licensed Medical Laboratory Scientist to analyze specimens and maintains equipment in good operating condition. PRIMARY RESPONSIBILITIES: Verify the proper specimen being analyzed and perform tests that need to be completed. Proficient at analyzing clinical laboratory specimens following the standard methods and procedures in an efficient manner with little to no errors. Responsible for maintaining updated understanding and knowledge of methods performed in the lab. Provides general oversight of personnel and the daily operations in the lab. Meet expected performance metrics within role as applicable. etc.

Analyzes specimens and maintains equipment in good operating condition. PRIMARY RESPONSIBILITIES: Verify the proper specimen being analyzed and perform tests that need to be completed. Proficient at analyzing clinical laboratory specimens following the standard methods and procedures in an efficient manner with little to no errors. Responsible for maintaining updated understanding and knowledge of methods performed in the lab. Follows GLP (good laboratory practice): maintain clean and organized workspace. Completes training and other deadlines on time. etc.

The Production Technician is responsible for the safe execution of the day to day operations of the production plant. This position will work closely with other team members and be responsible for personal and plant safety, environmental compliance, commitment to continuous improvement in the quality of our product, cost control efforts and efficient operations of the plant. This position requires working 12 hour shifts including evenings, weekends and holidays. etc.

As a Histotechnician I you will work under the direct supervision of a licensed physician or surgeon, or within a training environment. You will assist with responsibilities associated with processing specimens for clinical testing and providing general support for the laboratory following established policies and procedures. Receive, organize and process clinical specimens accurately; identify worksheet, computer, and specimen problems and demonstrate ability to either resolve or elevate to licensed personnel appropriately. Prepare and organize written data, printouts, and other documents for pathologist review. etc.

This position is in the Biotechnology R&D group and is primarily a bench level job focusing on real time PCR assay and product development in an FDA-QSR and ISO13485 compliant organization. The ideal candidate will have experience in general molecular biology methods such as nucleic acid extraction and real-time PCR. This candidate will assist in the development of novel assays for diagnosis and monitoring of microorganisms involved in infectious diseases. In addition to technical qualifications, the ideal candidate will be highly goal-oriented, inquisitive, organized, and be able to thrive in an atmosphere of shifting demands and priorities.

The Quality and Compliance Associate is a key member the company’s SOP Committee actively enforcing the company’s policies and procedures in alignment with the overall Quality Management System (QMS). Maintains and promotes company and regulatory quality standards. Conducts activities involving quality assurance and compliance with applicable requirements. Responds to compliance questionnaires

To assist in the development and licensure of viral, bacterial and/or recombinant vaccines as well as new label claims or product improvement research of the licensed vaccines. Propagate cell, virus, bacteria and recombinant organism stocks, perform the testing such as cell counting, titrations, ELISA and other biological and/or molecular assays. Participate in planning and executing from research to large production scale up projects

Immediate need for Validation Specialist with experience in the Pharmaceutical and Biotech industry generating and executing protocols for equipment and utilities. Good writing skills a must. Overtime and some travel may be required. Submit resume along with availability

Support in vivo oncology studies in mice as a member of the MDC Team. Receive, characterize and orthotopically or heterotopically surgically implant tissue samples. Conduct tumor volume measurements and sample collection for in vitro characterization.

Support in vivo oncology studies in mice as a member of the Vivarium Operations Team. Clean equipment, rooms and facility according to a schedule devised by senior personnel; including floor sweeping and washing, cage washing and sterilization, and waste removal. Provide animal care including feeding and watering with food and water consumption monitoring.

Reviews and complies with all policies pertaining to the animal care program. Cares for and maintains laboratory animals in accordance with USDA Animal Welfare Act and policies, the “Guide for the Care and Use of Laboratory Animals,” and other applicable regulations and policies. Works closely with the Veterinarian to perform daily health assessments of the large animals in the Surgical Services Program and maintain all records as needed and associated with this monitoring. Provides animal treatments as instructed by the Veterinarian. Performs technical functions required by research protocols, such as daily clinical observations, diagnostic testing, administering medications to post-operative animals and health examinations of sick animals, prior to reporting adverse findings to Veterinarian responsible for that area.

This position will be responsible for handling and processing samples, and performing accurate data collection and reporting. Basic methods will be used to perform laboratory tasks with minimal supervision in the performance of studies.

The Research Technician I will collect and record data with minimal supervision in the performance of studies. Responsible for handling and restraining animals, clinical observations, sample collection, monitoring food consumption, animal husbandry, and performing accurate data collection and reporting. Administer test substances by various basic methods.

The Research Technician I will collect and record data with minimal supervision in the performance of studies. Responsible for handling and restraining animals, clinical observations, sample collection, monitoring food consumption, animal husbandry, and performing accurate data collection and reporting. Administer test substances by various basic methods.

Perform routine analytical procedures utilizing a variety of analytical techniques with minimal supervision. Perform method development under the direction of a senior level chemist. Accurately record and document raw data, observations and pharmacy usage. Ensure that work conforms to appropriate regulatory requirements, including SOP’s, Protocols, US FDA and US EPA Good Laboratory Practices (GLP) and US FDA current Good Manufacturing Practices (cGMP).

Ability to write technical/scientifically detailed text reports according to established procedures and regulatory guidelines. Auditing and/or experience as an analytical chemist is preferable. Perform reporting functions for GLP/cGMP and R&D data as necessary. Ensure that work conforms to appropriate regulatory requirements, including SOP’s, US FDA and US EPA Good Laboratory Practices (GLP) and US FDA current Good Manufacturing Practices (cGMP).

This position is primarily responsible to perform assembly operations according to written procedures in the clean room environment meeting all quality standards. Be familiar with and follow operating requirements including GMPs (Good Manufacturing Practices) and specific customer defined requirements.

The primary purpose of the QC Analytical Chemist is to provide support to the Production and Formulations Departments by analyzing pharmaceutical and/or cleaning samples. Support will be provided by analyzing samples using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendial monographs, client procedures, and miscellaneous protocols. The QC Analytical Chemist is expected to understand basic internal procedures, and conduct analyses with some supervision after training is complete. In addition, support is provided by ensuring the essential job functions of this position are completed as part of the daily and/or weekly schedule.The primary purpose of the QC Analytical Chemist is to provide support to the Production and Formulations Departments by analyzing pharmaceutical and/or cleaning samples. Support will be provided by analyzing samples using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendial monographs, client procedures, and miscellaneous protocols. The QC Analytical Chemist is expected to understand basic internal procedures, and conduct analyses with some supervision after training is complete. In addition, support is provided by ensuring the essential job functions of this position are completed as part of the daily and/or weekly schedule.

The position will focus on implementing and utilizing state-of-the art automation, analytical and preparative scale chromatographic systems to deliver high quality compounds for drug discovery in the first in-class Automated Life Sciences Studio facility located in La Jolla, CA. Providing new options for the continuous development of processes and chromatographic methodologies that will improve the productivity, timeliness and scientific impact of analytical support.

Advanced Engineering group of BGI Research USA is seeking to bring a highly motivated fixed-term Research Associate candidate to provide aid with advanced microfluidic research and development under the direction of a project leader and/or senior engineers and scientists. Maintain and run different aspects of microfluidic systems – reagents, software, hardware. Conduct assays, fluidic and platform validation and verification tests by following defined protocols for microfluidic devices and analyze the data to generate testing reports.

We are currently seeking an associate scientist to support the projects related to metabolic engineering of plant and microbial secondary metabolites. This position will focus on protein engineering and the candidate is expected to have a strong background in protein engineering, biochemistry, molecular biology and be able to translate protein structural concepts into novel protein engineering strategies.

The Production Quality Engineer will be responsible for product quality engineering, quality assurance, and production process activities. They will be expected to provide support to Operations, interact with customers and provide support for Design Engineering, Quality Systems and Process Engineering. This position will be integral in meeting the Quality Management System requirements. It requires creativity and foresight to work with operations and product development teams to ensure compliance to the Quality Manual, Design Control, Supplier Management and other appropriate procedures from concept through market introduction.

The Quality Engineer, Non-Conformance at Cook Incorporated serves as the quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA. Interface with internal and external groups on quality-related issues. Perform investigation of product non-conformances and/or processes.

Research and Development Engineering is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices. Entry level engineer to develop new and improved Surgical Drapes and Gowns, Face Masks, Infection Control Apparel, sterilization wrap.

The Clinical Trial Assistant provides support to the clinical operations to assist with execution and maintenance of clinical studies. Acts as a central support for the clinical team for designated project communications, correspondence, and associated documentation. Maintains, updates, and may establish various databases for clinical activity tracking. Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites.

As a Research Assistant (Study Technician) in our Madison, WI In-Life department, you will monitor the research animals’ health and welfare using your experience in animal observation and your experience working with sample collections. Collection, documentation, and management of pertinent data from animal observations, test material administration, and clinical sample collection. Maintaining the facilities in accordance with the Association for Assessment and Accreditation of Laboratory Animal Care (AALAC)

To support this effort, we are seeking an Assembly and Test Technician to support the assembly of designed parts for the company’s core medical instruments. Within this role, you will be responsible for supporting all tasks and functions in producing interposer to chip assemblies, while inspecting incoming raw materials and maintaining inventory for all production parts. Overall, your keen ability to work with a multi-disciplinary team to lead and advance product development efforts will champion the continued success of Owl biomedical. etc.

As a member of Miltenyi Biotec’s Process Development team, you will have the exciting opportunity to support the development of new processes that will generate cellular therapeutic products. You will apply your GLP/GMP experience to perform and maintain cell cultures using aseptic techniques. Ideally, you will be able to order materials and maintain inventory with the goal in mind that every effort is aimed at developing and qualifying processes required for clinical cell and gene therapy products. etc.

As a member of the Lentigen Technology team, you will have the opportunity to perform duties within the area of development of new tests, including the development of a standard RCL test and in a second instance of an automatized RCL test. This includes the set-up of a standard test based on the use of C8166 cells, the characterization of the C8166 cells with respect to susceptibility and propagation of HIV over many cell passages, etc. A very issue related to this development is that the test has to comply with FDA requirements with at the end the transfer of the test to the QC department for routine use. etc.

Reporting to the Principal Scientist, Process Development, the Senior Research Associate, Drug Product Process Sciences will work with in vitro bioanalytical systems to evaluate samples from in vivo studies. The successful candidate will be able to deliver reproducible and impactful results under ambitious timelines. Here’s What You’ll Do: Develop and characterize lipid nanoparticle (LNP) formulations for delivery of mRNA. etc.

This is a Part-Time position. Your responsibilities as a Laboratory Assistant 1 are to maintain the animal facility at Bio-Techne and perform general lab duties. Responsible for the welfare and immunization of all rodents that are used within R & D Systems. Follows company policies and practices as outlined in the Handbook and follows guidelines regarding safety as outlined in the AWAIR, Chemical Hygiene and Exposure Control manuals in accordance to the job. General lab duties including stocking and organizing supplies and materials and preparing reagents.

The position involvesimplementation of HPLC, chromatography, enzyme assays, and gel-basedanalytical methods.Common tasks include analytical separations and quantitative analyses by:1) HPLC and column chromatographyincluding affinity chromatography, IEX, HIC, and SEC; 2) spectrophotometric enzyme assays; 3) sample preparation and extraction;and 4) basic antibody and protein analyses,usingELISA, protein extraction, protein concentration assays, SDS-PAGE, and Western blot.

Under the supervision of Biotium scientists, perform production and quality control testing of assay kit components following standardized protocols. Under the supervision of scientists, perform R&D assays to develop new fluorescence-based products. This individual will be responsible for production and QC of products, as well as play a role in the design,optimization and assessment of novel reagents for fluorescent detection technologies.

Meet or exceed sales objectives set by the BioVision management. Learn and master BioVision's product offering and manufacturing capabilities. Establish long-term relationships with the customers and match BioVision's capabilities with customer needs. Identify key contacts and decision makers to maximize the benefits from customer visits. Develop a customer-specific account management approach, identifying new business and growth opportunities

The primary purpose of the position is to execute projects, perform routine experiments and analyze data in the Upstream Manufacturing Science and Technology (MSAT) group. The position holder must live the BI values and promote a positive work environment for others. Has discretion in tactical execution of process improvement projects, investigations and experiments. Frequently executes routine and occasionally complex experiments with sound scientific and engineering principals to resolve problems with minimal oversight. The Engineer frequently executes against specific deliverables developed by the department leadership to improve operational efficiency.

The Lab Technician in the Microbiology Lab will perform routine laboratory tasks and assist laboratory personnel according to FDA, cGMP and Boston Analytical’s Standard Operating Procedures. Cleans and maintains laboratory glassware (including sterilization), equipment, and laboratory. Monitors and maintains water system, including sample collection for Bioburden, TOC, and Conductivity. Properly handles, stores and disposes of hazardous materials according to OSHA and Boston Analytical procedures.

he Chemist conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products using HPLC, GC, Dissolution, AA, UV-Vis, Wet Chemical Analysis and Method Development.

Provide Quality Technician support to Arden Hills commercial and development manufacturing lines ensuring delivery of the highest quality product to the customer while supporting continuous improvement projects and quality initiatives. This is a dynamic support role requiring cross-functional collaboration with production, manufacturing, and quality team members. This role includes responsibility for providing day-to-day quality support for manufacturing, including the processing of non-conforming product (identification, documentation, segregation evaluation and disposition), certifying builders and responding to quality signals.

This Quality Engineer role will investigate product complaints and monitor BSC product performance. The team uses product performance data to escalate post-market field performance signals into the CAPA process in collaboration with Return Device Analysis, R & D, Design Assurance, Medical Safety and the CAPA Management teams. This role provides for significant visibility across the quality organization

Daily planning operations supporting the manufacturing facility; planning for and ensuring availability of raw materials, components, and resources per the site’s detailed manufacturing schedule. Facilitate and coordinate activities with all departments to ensure the availability of raw materials for plant operations supporting development through commercial production. Review cGMP production records and perform associated inventory transactions in the ERP system.

Responsible for the support of clinical and commercial drug manufacturing in the new Viral Vector Manufacturing facility located at the Cambridge, MA campus. Scope includes designing, specifying, and supporting manufacturing systems such as DeltaV, Allen Bradley PLC and analytical equipment in our newly built viral vector manufacturing facility. Individual will be part of an experienced team of process and automation engineers working closely with groups such as manufacturing, quality assurance, quality control and validation.

Responsibilities include performing basic to moderately complex activities related to operating bioprocess manufacturing equipment, completing the associated documentation of those activities, monitoring assigned processes using automated production systems and controls. Other activities include keeping the GMP manufacturing facility in a state of inspection readiness, using performance tools (Human Performance), and routine housekeeping activities. Must be technically capable with a basic theoretical comprehension of general biopharmaceutical manufacturing equipment, principles and processes and have a basic understanding of current GMP and safety standards.

Associate I, Manufacturing is an associate with a moderate level of technical expertise and experience. Associate I may perform complex activities outside of routine manufacturing operations commensurate with their experience and training. Associate I participates in the day to day operation of a cGMP compliant Manufacturing facility. Responsibilities include performing basic to complex activities related to operating bioprocess manufacturing equipment, completing the associated documentation of those activities, monitoring assigned processes using automated production systems and controls under limited supervision. Other activities include keeping the GMP manufacturing facility in a state of inspection readiness, using performance tools (Human Performance), and routine housekeeping activities.

The Manufacturing Technology Associate Engineer will support Manufacturing Operations (Downstream processing, column packing) on a daily basis, as well as lead or contribute to strategic projects. Support projects and identify opportunities for productivity, robustness, quality, business process, and safety improvements. Regular and frequent on-floor observation to support and improve manufacturing.

Support Multi-Million Dollar Fiber Processing and De-inking Assets, working in a Team environment, handling raw materials and finished Tissue parent rolls as necessary. 

This position reports to an engineer on the Dialysis Team.  An R&D technician helps with the generation of test protocols and reports, tests products and reports results, and helps to design and maintain test fixturing.  In addition, they may help with troubleshooting and test development. Assists in the execution of test protocols, methods and procedures. Sets up and operates test equipment and records measurements with limited supervision

The Clinical Laboratory Assistant (CLA) performs a variety of laboratory and administrative tasks to support the clinical laboratory staff in the CLIA-certified CareDx laboratory. A CLA performs laboratory duties under direct and constant supervision of a licensed CLS or the Clinical Laboratory Manager (CLM) and/or designee, who provides specific instruction regarding how tasks are to be completed and defines the steps to be employed.

The candidate must be motivated, enthusiastic, professional and committed to working as a team player.  The ideal candidate enlists confidence, comfort and a working knowledge of laboratory animals, with a background in animal husbandry, restraint and handling.  In addition, experience with injection (IV, IP, SC, and PO) and blood draw techniques (RO bleed and cardiac puncture), along with rodent surgery and anesthesia experience is desirable.  The candidate must have the ability to effectively communicate with coworkers, take direction from supervisors, and be accountable for their actions.

The individual should possess strong core competencies in cell biology, molecular biology, assay development. We are seeking a qualified candidate who will share our excitement about the science, contribute to our culture, and honor our commitment to patients. Perform western blotting, FACS and imaging analysis to analyze autophagy and specific target activity in primary cells and cell lines. Cell culture and cell line development using retro- and lenti-virus, CRISPR and downstream analysis of autophagy and signaling.

The Assistant Scientist, Upstream Process Development will perform a variety of laboratory procedures to support Upstream Process Development. The position will perform daily work assignments accurately and in a timely and safe manner. This position will independently evaluate, select and apply standardized scientific and techniques; assignments have clear and specified objectives, and require the investigation of a limited number of variables. This position relies on limited experience and exercises judgment within defined procedures and practices in making minor adaptations and modifications.

Catalent has an entry level Associate, Biomanufacturing position available.  As an Associate, Biomanufacturing  you will perform aseptic techniques within a clean room environment. You will learn to execute and properly document current good manufacturing practices (cGMP) activities. This is a second shift position.  Work hours are Sunday to Wednesday (4/10).

This a great entry-level opportunity for a new grad looking to gain hands-on industry experience and learn a variety of lab techniques. The Analytical Chemist I will be expected to understand and execute basic analytical procedures in order to assess the quality of pharmaceutical API, intermediates, and final drug products under limited supervision. Duties may include the preparation of simple aqueous and organic buffered solutions, volumetric dilution of samples and standards using good laboratory techniques, clear and accurate record keeping in laboratory notebooks, use of analytical instrumentation to acquire raw data, calculation and reporting of final results. The Chemist I will begin to develop product-specific cleaning methods to support use of GMP manufacturing equipment. 

As the Laboratory Equipment Maintenance Technician, you will be responsible for assisting in the maintenance of bioanalytical equipment. This position offers a chance to work on a wide variety of laboratory equipment that is vital to the clinical research process. Assists with the setup, operation, evaluation and troubleshooting all types of bioanalytical laboratory instruments, including interfacing with LCMSMS, pumps, water baths, plate washers, plate readers, incubators, etc.

FUJIFILM Cellular Dynamics, Inc in Madison, WI is recruiting for a laboratory technician.   This role provides an outstanding opportunity for talented and self-motivated individuals working with our R&D teams.  Ideal candidates will have exposure to cell culturing and will be interested in advancing their career to support our ongoing efforts to generate differentiated cell types from human induced pluripotent stem cells.   We are most interested in connecting with qualified individuals who aspire to support the development of therapeutics and life science products and tools to support research endeavors.  In return we provide development and support to enhance your career development in the field of  cutting edge iPSC technology.

The Customer Service Representative I will provide professional, courteous, customer-centric service to the MSD customer base. This individual will directly interact with various customers and interface with multiple internal departments to facilitate the processing of quotes, orders and customer requests to allow for timely shipping of MSD products worldwide. etc.

A Research Associate is responsible for independently designing and executing experiments and analyzing the resulting data in support of reagent and assay development projects. This is a laboratory based position performing protein-based immunoassays on a routine basis with relatively high throughput (3-10 plates per day). The incumbent is expected to display a wide-degree of latitude, creativity and self-management. etc.

Essential Responsibilities: Manages incoming calls; respond to customer inquiries and/or direct calls accordingly. Receive and process orders received via phone, email, fax, website, Electronic Data Interchange (EDI) or other type of electronic Purchase Order system; calculates charges and process invoices. Review product availability and order status in the company ERP system (NetSuite). Open customer accounts in NetSuite. etc.

There are two openings. These positions are responsible for basic and routine tasks involved in the manufacture and assembly of the company's disposable test cartridges. Responsibilities: Follow written procedures for set-up, operation, and clean up of manufacturing equipments, final assembly, and packaging. Responsible for manual tasks including, pipette solution, pouch and box labeling, product inspection. Prepare materials used in the cartridge production process. etc.

Performs the assembly or sub-assembly of medical devices and products in an advanced position under moderate supervision from line leaders and supervisors in accordance with manufacturing documents and verbal instructions. Using written and verbal instruction to assemble and package product. Records data associated with the building of product on builds records. Ability to meet quality standard. Perform job function within production standard on 2-5 operations. Work with engineers and supervisors to perform special assembly requests

The Engineer I/Engineer II, Manufacturing Process is responsible for the improvement, sustaining, development, and overall support of new and existing manufacturing processes for new and existing products, product changes and enhancements, as well as related tooling and fixtures. Supports validation of product, equipment and processes. Interfaces with other departments to solve production problems. Monitor equipment maintenance program. Investigation and testing of product processes. etc.

Quality Associate performs daily quality review of raw material documentation to ensure that materials being received are produced in accordance to Company methodology, procedures, and standards. Quality Associate completes Change Control, Supplier Quality, and Nonconformance and Corrective Action Preventive Action (CAPA) quality records related to Receiving & Inspection. Quality Associate is SME for Receiving & Inspection procedures and manages projects.

Over the course of two years, the TDP participant will complete four x 6-month rotations, with the option to combine two rotations into a single 12 month rotation.  The rotations will be based in Research and Development at Baxter’s Round Lake, IL, and Deerfield, IL, locations.  Participants can optionally have the opportunity to travel to or work from other Baxter Research and Development sites across the globe. 

The entry level firmware engineer is an integral position within the Hach R&D team. The engineer will be part of a fast paced team, working in a collaborative environment that will drive growth and innovation within the firmware competency. The engineer will engage with SCRUM in an Agile team environment with the core responsibility of developing high quality innovative solutions.

The Laboratory Operations Specialist I, in the Bioanalytical division, is an entry-level Laboratory Operations Specialist who will work primarily in our lab and they will be accessioning clinical samples, following SOPs, documenting all work performed and will assist with QA tasks.

As a member of the BGIA Support team, the position will support next generation processes for genome sequencing. The successful candidate will be responsible for developing and executing standard work procedures on a wide range of molecular biology techniques related to Next Generation Sequencing.

The Procurement Associate will work directly for the Procurement Manager to assist in the operational procurement at the departmental level. He/She will own the procurement process for the department in scope and ensure compliance, budgets and corporate strategy.  He/She will have responsibility for negotiating pricing arrangements.  He/she will work closely with the finance, accounts payable, legal, and quality control.

Performs DXA analysis and quality control in accordance with study-specific deliverables and within study-specific turnaround times. Understands functions of software used to produce and collect DXA image analysis results. Communicates with Clinical Project Managers, Imaging Research Associates and/or Scientific Director regarding image quality, deliverables, and data discrepancies.

Test Processing Support Specialist 1 duties will consist of accurately and precisely transferring and entering data from test request forms into an electronic data base. Confirmation of entered data, and confirmation that data provided meets the minimum requirements as indicated by the QMS. Timely and accurate delivery of reviewed test results.

The Senior Quality Assurance Associate assists in execution of systems to assure cGMP compliance for all relevant operations carried out within and for BioDuro, LLC.  This function includes: Analytical Support – Support functions include, but are not limited to: review and approval of in-process testing, release testing of products, stability testing, other data summaries, method validation data, laboratory equipment validation protocols, product certificates of analysis, generation of environmental chamber monitoring reports. Other duties as deemed appropriate by Head of Quality.

This position will focus on development of high productivity and robust cell culture processes through classically and statistically designed experiments. The candidate’s goals will be to increase process robustness and productivity through comprehensive understanding of levers important to mammalian cell culture. A major component of the role will involve conducting and documenting laboratory bioreactor experiments with a focus on process definition and understanding, experimental design and troubleshooting, and data analysis. The ideal candidate will be able to work collaboratively with pilot scale and tech transfer teams for execution of development projects. In addition, the ideal candidate will contribute to improving laboratory process workflows, making laboratory work more efficient and with greater impact.

The individual will assist in the development and optimization of formulations and provide technical expertise on preparation procedures and mixing process parameters using both practical and scientific knowledge. Will work as member of dynamic team developing and following established procedures to ensure a consistent service is delivered. Management of department chemical and consumable inventories, ensuring proper levels are available. Frequent collaboration and communication with multiple line functions to develop solution formulations and preparation process instructions.

This position is responsible for developing immunoassay products in the Biomarker Immunoassay group. The Research Associate will be involved in all aspects of the product development processes including designing, initiating, testing, troubleshooting, testing materials manufacturing, technical instruction transferring, and product launching. More specifically, he or she will be working closely with an experienced scientist on developing a line of product utilizing ELISA or bead-based immunoassay and flow cytometry technologies.

The Material Coordinator is an entry level role that will support corporate business development efforts to expand company product portfolio through in-licensing, in-house development, and other methods of acquisition. This position will be responsible for documenting, receiving, and distributing incoming materials to stakeholders within the facility and outside locations and will work in a collaborative environment with other internal departments including Finance, Customer Service, Research and Development, Purchasing, Facilities and Quality Assurance.